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Trial record 84 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00385671
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : October 18, 2010
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Interventions Drug: duloxetine hydrochloride
Drug: pregabalin
Drug: gabapentin
Enrollment 407
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks. Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks. Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Period Title: Overall Study
Started 134 138 135
Completed 96 87 99
Not Completed 38 51 36
Reason Not Completed
Adverse Event             14             27             18
Lack of Efficacy             5             9             5
Lost to Follow-up             6             6             5
Physician Decision             2             1             2
Protocol Violation             5             2             1
Sponsor Decision             2             2             1
Withdrawal by Subject             4             4             4
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine Total
Hide Arm/Group Description Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks. Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks. Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks. Total of all reporting groups
Overall Number of Baseline Participants 134 138 135 407
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 138 participants 135 participants 407 participants
61.89  (10.70) 60.94  (10.18) 61.85  (10.84) 61.56  (10.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Female
58
  43.3%
55
  39.9%
52
  38.5%
165
  40.5%
Male
76
  56.7%
83
  60.1%
83
  61.5%
242
  59.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Native American 1 1 1 3
East Asian 0 0 2 2
Hispanic 9 15 9 33
Black or African American 13 9 11 33
White 111 110 112 333
West Asian 0 3 0 3
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
United States 104 112 109 325
Germany 22 20 21 63
Canada 5 4 3 12
Puerto Rico 3 2 2 7
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 134 participants 138 participants 135 participants 407 participants
150.26  (131.60) 147.14  (116.04) 119.82  (93.38) 139.09  (115.24)
Duration of Diabetic Peripheral Neuropathic Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 134 participants 138 participants 135 participants 407 participants
51.54  (40.96) 58.08  (57.57) 50.32  (41.93) 53.34  (47.51)
[1]
Measure Description: Duration of Diabetic Peripheral Neuropathic Pain Since Onset.
Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment - Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
5.91  (1.56) 5.73  (1.58) 5.94  (1.56) 5.86  (1.56)
[1]
Measure Description: Assesses degree of neuropathy. Responses to 13 out of 15 items are added to obtain total score. Responses of “yes” to items 1,2,3,5,6,8,9,11,12,14,15 are each counted as one point. A “no” response on items 7 and 13 counts as 1 point. Items 4 and 10 are not included in scoring. Total scores range from 0 (no neuropathy) to 13 (severe neuropathy).
Types of Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Type I 13 9 9 31
Type II 121 129 126 376
Weekly mean of 24 hour average pain severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
5.69  (1.43) 5.81  (1.51) 5.78  (1.47) 5.76  (1.47)
[1]
Measure Description: This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.
Beck Depression Inventory (BDI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
9.45  (8.53) 9.10  (7.20) 10.71  (8.42) 9.74  (8.07)
[1]
Measure Description: A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Weekly mean of the daily worst pain severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
6.92  (1.56) 7.12  (1.46) 7.05  (1.48) 7.03  (1.50)
[1]
Measure Description: This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.
Weekly mean of nighttime pain severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
5.64  (2.06) 5.86  (1.74) 5.55  (2.11) 5.69  (1.97)
[1]
Measure Description: This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.
Leeds Sleep Evaluation Questionnaire (LSEQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Awakening Subscale 93.95  (41.55) 88.63  (40.75) 86.70  (42.46) 89.75  (41.59)
Behavior Following Wakefulness Subscale 132.22  (69.22) 128.87  (65.53) 131.55  (69.61) 130.88  (67.98)
Getting to Sleep Subscale 138.62  (59.68) 137.61  (62.91) 145.22  (64.73) 140.45  (62.40)
Quality of Sleep Subscale 95.54  (44.08) 95.89  (46.82) 97.01  (45.39) 96.15  (45.34)
[1]
Measure Description: The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behvior. Subscale score ranges: going to sleep=0-300, quality of sleep=0-200, awakening=0-200, behavior following wakefullness=0-300.
Sheehan Disability Scale (SDS) Global Functional Impairment Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
11.44  (8.72) 13.49  (9.00) 12.69  (7.92) 12.55  (8.58)
[1]
Measure Description: The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
Clayton Sexual Functioning Questionnaire (CSFQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 134 participants 138 participants 135 participants 407 participants
male participants - total 40.41  (9.01) 38.81  (9.50) 39.25  (9.75) 39.46  (9.42)
female participants - total 35.21  (11.68) 36.69  (10.43) 34.45  (10.09) 35.43  (10.73)
male participants - arousal 7.19  (3.08) 6.35  (2.88) 6.41  (3.12) 6.64  (3.04)
female participants - arousal 6.64  (3.20) 7.00  (2.72) 6.47  (3.09) 6.70  (3.01)
male participants - desire/frequency 5.32  (1.73) 5.09  (1.77) 5.15  (1.96) 5.18  (1.82)
female participants - desire/frequency 3.79  (1.85) 4.27  (1.83) 3.74  (1.59) 3.93  (1.77)
male participants - desire/interest 7.71  (2.56) 7.91  (2.72) 8.06  (2.84) 7.90  (2.71)
female participants - desire/interest 5.96  (3.01) 5.97  (2.42) 5.72  (2.43) 5.89  (2.63)
male participants - orgasm 7.77  (2.93) 7.21  (2.85) 7.51  (3.06) 7.49  (2.94)
female participants - orgasm 6.98  (3.75) 8.23  (3.94) 7.53  (3.83) 7.56  (3.84)
male participants - pleasure 2.43  (1.23) 2.50  (1.22) 2.30  (1.11) 2.41  (1.19)
female participants - pleasure 2.06  (1.19) 2.23  (1.18) 2.06  (1.13) 2.12  (1.16)
[1]
Measure Description: The CSFQ is a 14-item subject-rated scale designed to assess changes in sexual activity and functioning. The CSFQ is a structured interview/questionnaire, which is designed to measure medication related changes in sexual functioning. The CSFQ measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The CSFQ total score is also obtained across all 5 dimensions and ranges from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores indicate greater changes.
Comorbidity with Generalized Anxiety Disorder (GAD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Yes 3 0 1 4
No 131 138 134 403
[1]
Measure Description: Frequency of current comorbid Generalized Anxiety Disorder-Text-Revised (DSM-IV-TR) based on specific modules of the Mini-International Neuropsychiatric Interview (MINI), a short, structured diagnostic interview developed for DSM-IV psychiatric disorders.
Comorbidity with Major Depressive Disorder (MDD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 138 participants 135 participants 407 participants
Yes 4 3 4 11
No 130 135 131 396
[1]
Measure Description: Frequency of current comorbid Major Depressive Disorder-Text revision (DSM-IV-TR) based on specific modules of the Mini-International Neuropsychiatric Interview (MINI), a short, structured diagnostic interview developed for DSM-IV psychiatric disorders.
1.Primary Outcome
Title Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
Hide Description This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 93 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.12  (0.19) -2.62  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin & duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.
Statistical Test of Hypothesis P-Value 0.076
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week, Kenward-Roger approximation was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
-0.05 to 1.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin
Hide Description This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Gabapentin + Duloxetine Duloxetine
Hide Arm/Group Description:
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 86 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.39  (0.20) -2.62  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gabapentin + Duloxetine, Duloxetine
Comments Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine & duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.
Statistical Test of Hypothesis P-Value 0.417
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week, Kenward-Roger approximation was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.32 to 0.78
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity
Hide Description This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 120 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.30  (0.21) -2.71  (0.22) -2.49  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.520
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
4.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score
Hide Description This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 120 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.59  (0.22) -3.08  (0.24) -2.86  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
5.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)
Hide Description Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 117 125 120
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.27  (0.85) 4.47  (0.90) 4.40  (0.79)
change -1.06  (0.10) -1.16  (0.10) -1.13  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.20 to 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.17 to 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.24 to 0.30
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks
Hide Description A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 122 125 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.03  (1.19) 3.01  (1.68) 2.83  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Variance model and t-tests:

Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.16 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Variance model and t-tests:

Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.33 to 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Variance model and t-tests:

Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.53 to 0.17
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain
Hide Description A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 5.53  (1.87) 5.65  (1.72) 5.75  (1.76)
change -1.80  (0.20) -2.44  (0.21) -2.29  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
-0.06 to 1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.08 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.41 to 0.70
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain
Hide Description A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 6.73  (2.01) 6.87  (2.06) 7.00  (1.83)
change -2.34  (0.23) -3.02  (0.25) -2.64  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.34 to 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.03 to 1.34
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.27 to 1.04
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain
Hide Description A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.23  (2.28) 4.18  (2.11) 4.07  (2.14)
change -1.27  (0.19) -1.55  (0.20) -1.54  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.25 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.25 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.989
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.53 to 0.54
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now
Hide Description A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.98  (2.33) 5.03  (2.30) 5.36  (2.18)
change -1.77  (0.21) -2.24  (0.22) -2.19  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.14 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-0.11 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.865
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.52 to 0.62
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.24  (2.67) 5.03  (2.65) 5.03  (2.48)
change -1.51  (0.22) -2.38  (0.23) -1.86  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.263
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.26 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.24 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.10 to 1.13
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 3.42  (2.73) 4.08  (2.66) 4.10  (2.67)
change -1.46  (0.21) -1.85  (0.23) -1.43  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.61 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.20 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-0.17 to 1.02
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 5.25  (2.72) 5.52  (2.85) 5.79  (2.53)
change -1.88  (0.24) -2.56  (0.26) -2.09  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.46 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
-0.00 to 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
-0.21 to 1.15
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.61  (2.86) 4.98  (2.86) 5.15  (2.54)
change -1.63  (0.24) -1.86  (0.25) -1.88  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.40 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.43 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.969
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.68 to 0.65
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 2.96  (2.68) 3.08  (2.72) 3.29  (2.58)
change -0.97  (0.21) -1.27  (0.22) -1.17  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.479
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.36 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.27 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.731
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.47 to 0.67
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.91  (2.87) 4.97  (2.94) 5.40  (2.81)
change -2.29  (0.24) -2.12  (0.26) -2.50  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.45 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.626
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.84 to 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.06 to 0.30
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.38  (3.08) 4.63  (2.96) 5.02  (2.68)
change -1.82  (0.22) -2.09  (0.24) -2.33  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.10 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.35 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.86 to 0.39
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score
Hide Description The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 128 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
baseline 4.25  (2.34) 4.61  (2.36) 4.83  (2.13)
change -1.62  (0.20) -2.00  (0.21) -1.90  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.309
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.26 to 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-0.17 to 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.45 to 0.65
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks
Hide Description This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 120 125
Measure Type: Number
Unit of Measure: participants
65 68 72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
20.Secondary Outcome
Title Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score
Hide Description This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 120 125
Measure Type: Number
Unit of Measure: participants
48 50 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.548
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
21.Secondary Outcome
Title Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks
Hide Description This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 127 120 125
Measure Type: Number
Unit of Measure: participants
59 64 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method Mantel Haenszel
Comments Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.
22.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)
Hide Description The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 124 119 118
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
GTS, n=122, n=119, n=118 10.96  (4.83) 17.40  (5.06) 14.75  (4.92)
QOS, n=121, n=118, n=118 9.32  (4.01) 7.39  (4.24) 9.64  (4.06)
AFS, n=122, n=118, n=118 10.02  (3.71) 8.14  (3.92) 11.86  (3.73)
BFW, n=124, n=115, n=118 19.67  (5.65) 21.04  (6.03) 14.33  (5.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.734
Comments P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.498
Comments P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.865
Comments P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.
Method Mixed Models Analysis
Comments Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation
23.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3
Hide Description The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 118 124 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total -4.96  (0.66) -3.47  (0.65) -4.54  (0.66)
Item 1 -1.96  (0.31) -1.21  (0.33) -1.95  (0.32)
Item 2 -1.64  (0.24) -1.12  (0.23) -1.53  (0.24)
Item 3 -1.70  (0.22) -1.17  (0.22) -1.54  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-2.18 to 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-3.24 to 0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-2.80 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
Comments P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.88 to 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.63 to 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-1.59 to 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.733
Comments P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.75 to 0.52
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.15 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-1.04 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.76 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.12 to 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.95 to 0.22
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation
Hide Description [Not Specified]
Time Frame baseline through 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled in the study.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 134 138 135
Measure Type: Number
Unit of Measure: participants
Nausea 0 4 4
Peripheral Oedema 5 0 0
Insomnia 0 4 0
Somnolence 1 2 0
Anxiety 0 1 1
Dizziness 0 0 2
Dysuria 0 2 0
Headache 0 2 0
Hyperhidrosis 0 1 1
Sedation 1 0 1
Allergic Oedema 1 0 0
Anorgasmia 0 1 0
Increased Blood Creatine 0 0 1
Increased Blood Glucose 1 0 0
Bruxism 0 1 0
Cerebrovascular Accident 0 1 0
Chest Discomfort 0 0 1
Depression 0 1 0
Dermatitis 0 1 0
Diarrhoea 0 0 1
Dry mouth 0 1 0
Enterovirus Infection 0 0 1
Fatigue 0 1 0
Generalized Oedema 1 0 0
Facial Hypoaesthesia 1 0 0
Lacunar Infarction 1 0 0
Loss of Consciousness 0 1 0
Lymphoma 0 0 1
Mental Impairment 1 0 0
Muscular Weakness 0 0 1
Myoclonus 0 1 0
Pollakiuria 0 0 1
Pulomnary Embolism 0 0 1
Rash 0 0 1
Sleep Disorder 0 1 0
Urticaria 1 0 0
Vomiting 0 1 0
25.Secondary Outcome
Title Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores
Hide Description 14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.
Arm/Group Title Pregabalin Duloxetine Gabapentin + Duloxetine
Hide Arm/Group Description:
Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Overall Number of Participants Analyzed 101 109 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
male, total; n=62, n=67, n=66 -0.53  (0.80) 0.48  (0.77) 1.29  (0.79)
female, total; n=39; n=42, n=43 -0.01  (1.10) 1.12  (1.10) -0.61  (1.08)
male, pleasure; n=64, n=67, n=69 0.08  (0.12) -0.06  (0.11) 0.13  (0.11)
female, pleasure; n=40, n=42, n=43 0.15  (0.16) 0.47  (0.16) -0.09  (0.16)
male, desire/frequency; n=65, n=67, n=69 -0.02  (0.16) 0.06  (0.16) 0.16  (0.16)
female, desire/frequency; n=42, n=42, n=43 0.21  (0.21) 0.26  (0.22) 0.30  (0.21)
male, desire/interest; n=65, n=67, n=70 -0.27  (0.24) -0.19  (0.24) 0.05  (0.24)
female, desire/interest; n=42, n=42, n=45 -0.17  (0.32) 0.34  (0.33) 0.01  (0.32)
male, arousal; n=65, n=67, n=70 0.17  (0.26) 0.52  (0.26) 0.52  (0.26)
female, arousal; n=40, n=42, n=45 -0.11  (0.34) 0.07  (0.35) -0.30  (0.33)
male, orgasm; n=64, n=67, n=69 -0.39  (0.27) 0.18  (0.26) 0.17  (0.26)
female, orgasm; n=40, n=42, n=43 0.31  (0.39) -0.05  (0.40) -0.85  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.82
Confidence Interval (2-Sided) 95%
-3.96 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-3.16 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
-1.27 to 2.88
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.682
Comments P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
-2.29 to 3.48
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.
Method t-test, 2 sided
Comments

Analysis of Covariance model and t-tests:

Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.

Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-4.08 to 1.82
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Gabapentin + Duloxetine
Comments Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]