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Trial record 36 of 89 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673452
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : June 24, 2010
Last Update Posted : June 24, 2010
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: duloxetine hydrochloride
Drug: placebo
Enrollment 530
Recruitment Details  
Pre-assignment Details All patients were on duloxetine in the continuation phase. The continuation phase was for exploratory purpose only, and the results will not be presented further.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 60-120 mg, oral, daily, 12 weeks oral, daily, 12 weeks
Period Title: Acute Double-Blind Phase
Started 263 267
Completed 176 187
Not Completed 87 80
Reason Not Completed
Adverse Event             41             24
Lack of Efficacy             9             14
Lost to Follow-up             16             19
Physician Decision             0             6
Protocol Violation             5             3
Sponsor Decision             0             1
Withdrawal by Subject             16             13
Period Title: Continuation Double-Blind Phase
Started 176 187 [1]
Completed 151 153
Not Completed 25 34
Reason Not Completed
Adverse Event             5             13
Withdrawal by Subject             9             5
Lost to Follow-up             4             5
Lack of Efficacy             2             5
Protocol Violation             2             3
Sponsor Decision             0             3
Physician Decision             2             0
Death - Cervical vertebral fracture             1             0
[1]
Patients on placebo in acute phase received 60 mg duloxetine during the continuation phase.
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description 60-120 mg, oral, daily, 12 weeks oral, daily, 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 263 267 530
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants 267 participants 530 participants
50.74  (11.26) 49.62  (10.84) 50.18  (11.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Female
244
  92.8%
250
  93.6%
494
  93.2%
Male
19
   7.2%
17
   6.4%
36
   6.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Caucasian 204 206 410
Hispanic 37 46 83
Other - Not Specified 22 15 37
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 263 participants 267 participants 530 participants
263 267 530
Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Yes 89 90 179
No 174 177 351
Generalized Anxiety Disorder (GAD) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Yes 19 24 43
No 244 243 487
[1]
Measure Description: GAD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Major Depressive Disorder (MDD) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Yes 44 53 97
No 219 214 433
[1]
Measure Description: MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Tobacco Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 267 participants 530 participants
Yes 57 42 99
No 206 225 431
Beck Anxiety Inventory (BAI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
12.83  (9.28) 13.18  (9.77) 13.00  (9.52)
[1]
Measure Description: Beck Anxiety Inventory (BAI) is a 21-item patientcompleted questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
Beck Depression Inventory II (BDI-II) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
16.16  (10.43) 16.20  (10.35) 16.18  (10.38)
[1]
Measure Description: Beck Depression Inventory-II (BDI-II) is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
Brief Pain Inventory (BPI) Average Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
6.45  (1.54) 6.46  (1.62) 6.45  (1.58)
[1]
Measure 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).
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 263 participants 267 participants 530 participants
163.00  (8.38) 163.75  (8.48) 163.38  (8.43)
Likert Scale Rating of Mood, Anxiety, Sleep, Pain, and Stiffness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
Anxiety 3.68  (2.81) 4.08  (2.90) 3.88  (2.86)
Mood 3.78  (2.76) 4.04  (2.77) 3.91  (2.77)
Pain 7.25  (1.87) 7.45  (1.83) 7.35  (1.85)
Sleep 6.74  (2.56) 6.81  (2.67) 6.78  (2.62)
Stiffness 7.02  (2.00) 7.12  (1.84) 7.07  (1.92)
[1]
Measure Description: Patient-rated likert scale assessment of: Mood - feeling low, sad or depressed (0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad, or depressed); Anxious - anxious feelings (0 = not feeling anxious to 10 = extremely anxious); Sleep - how much patient is bothered by sleep difficulties (0 = not bothered to 10 = extremely bothered); Pain - how much patient is bothered by painful physical discomforts (0 = not bothered to 10 = extremely bothered); Stiffness - how stiff patient has felt in past 24 hours (0 = has not felt any stiffness to 10 = has felt extremely stiff).
Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
26.71  (6.33) 26.63  (6.29) 26.67  (6.30)
[1]
Measure Description: The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42.
Patient’s Global Impressions of Severity (PGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
3.88  (1.24) 3.66  (1.43) 3.77  (1.34)
[1]
Measure Description: The PGI-Severity scale is a patient-rated instrument that measures perceived severity of symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “Normal, not at all ill,” a score of 4 indicates that the patient has experienced “Moderately ill,” and a score of 7 indicates that the patient is “Among the most extremely ill patients.”
The Multidimensional Fatigue Inventory (MFI) Dimension Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 263 participants 267 participants 530 participants
General Fatigue Dimension 17.05  (2.91) 17.16  (2.87) 17.11  (2.89)
Mental Fatigue Dimension 13.28  (4.17) 12.97  (4.30) 13.12  (4.24)
Physical Fatigue Dimension 15.48  (3.50) 15.40  (3.61) 15.44  (3.55)
Reduced Activity Dimension 13.78  (4.06) 13.57  (3.90) 13.67  (3.98)
Reduced Motivation Dimension 12.41  (3.69) 12.59  (3.70) 12.50  (3.70)
[1]
Measure Description: The Multidimensional Fatigue Inventory (MFI) is a 20- item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 263 participants 267 participants 530 participants
84.01  (19.76) 85.98  (21.65) 85.00  (20.74)
1.Primary Outcome
Title Patient's Global Impressions of Improvement (PGI-I) at Week 12
Hide Description The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 245 255
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.79  (0.10) 3.36  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of –0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.
2.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
Hide Description BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). 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. Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 249 258
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain Severity -2.32  (0.17) -1.57  (0.17)
Least Pain Severity -1.57  (0.14) -0.96  (0.14)
Average Pain Severity -2.14  (0.15) -1.40  (0.15)
Pain Right Now Severity -2.10  (0.17) -1.34  (0.17)
General Activity Interference -2.38  (0.17) -1.44  (0.17)
Mood Interference -2.56  (0.18) -1.61  (0.18)
Walking Ability Interference -2.16  (0.17) -1.36  (0.17)
Normal Work Interference -2.37  (0.17) -1.60  (0.17)
Relations with Other People Interference -2.17  (0.17) -1.22  (0.16)
Sleep Interference -2.69  (0.18) -1.81  (0.18)
Enjoyment of Life Interference -2.84  (0.19) -1.45  (0.19)
Average Interference -2.44  (0.16) -1.52  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.19 to -0.31
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.99 to -0.24
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-1.13 to -0.35
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.20 to -0.31
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.39 to -0.49
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.41 to -0.49
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.24 to -0.36
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.21 to -0.32
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.38 to -0.52
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.35 to -0.39
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-1.92 to -0.86
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-1.33 to -0.52
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
3.Secondary Outcome
Title Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
Hide Description MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 246 254
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
General Fatigue -2.21  (0.22) -1.38  (0.22)
Physical Fatigue -2.08  (0.22) -1.35  (0.22)
Mental Fatigue -2.01  (0.23) -1.09  (0.23)
Reduced Activity -1.46  (0.24) -0.59  (0.23)
Reduced Motivation -1.66  (0.22) -0.72  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.41 to -0.25
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.30 to -0.15
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.52 to -0.32
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.49 to -0.26
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.49 to -0.38
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
4.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
Hide Description BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 233 237
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.53  (0.53) -3.63  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-3.25 to -0.53
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
Hide Description The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 231 237
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.05  (0.07) -0.71  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.51 to -0.16
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
6.Secondary Outcome
Title Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
Hide Description BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 230 232
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.14  (0.46) -3.22  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.907
Comments The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-1.13 to 1.27
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
7.Secondary Outcome
Title Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
Hide Description The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 232 235
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Bodily Pain 18.48  (1.33) 13.26  (1.32)
General Health 9.33  (1.16) 2.91  (1.15)
Mental Health 10.05  (1.17) 2.61  (1.15)
Physical Functioning 13.52  (1.31) 8.06  (1.30)
Role-Emotional 14.91  (2.57) 5.13  (2.54)
Role-Physical 20.49  (2.51) 18.90  (2.48)
Social Functioning 14.16  (1.52) 7.49  (1.50)
Vitality 12.78  (1.34) 8.47  (1.32)
Physical Component Summary (PCS) 5.96  (0.58) 4.81  (0.57)
Mental Component Summary (MCS) 5.11  (0.69) 1.28  (0.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
1.76 to 8.67
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.42
Confidence Interval (2-Sided) 95%
3.41 to 9.43
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 7.44
Confidence Interval (2-Sided) 95%
4.41 to 10.47
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.47
Confidence Interval (2-Sided) 95%
2.06 to 8.88
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 9.78
Confidence Interval (2-Sided) 95%
3.11 to 16.45
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.632
Comments P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
-4.93 to 8.11
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.67
Confidence Interval (2-Sided) 95%
2.73 to 10.61
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 4.31
Confidence Interval (2-Sided) 95%
0.84 to 7.79
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
-0.35 to 2.64
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 3.83
Confidence Interval (2-Sided) 95%
2.05 to 5.60
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
8.Secondary Outcome
Title Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
Hide Description The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 246 254
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.88  (0.42) -3.92  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-2.05 to 0.13
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
9.Secondary Outcome
Title Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
Hide Description Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a non-missing baseline and at least one post-baseline record.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 249 258
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Mood -1.27  (0.17) -0.52  (0.16)
Anxiety -1.22  (0.16) -0.58  (0.16)
Pain -2.45  (0.18) -1.73  (0.18)
Sleep -1.96  (0.19) -1.47  (0.18)
Stiffness -2.54  (0.17) -1.67  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.18 to -0.32
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.05 to -0.22
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.19 to -0.25
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.97 to -0.00
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.32 to -0.43
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
10.Secondary Outcome
Title Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
Hide Description Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with baseline and at least one post-baseline data.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 249 258
Measure Type: Number
Unit of Measure: participants
119 88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments A priori threshold for statistical significance is 0.05.
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
Hide Description Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with baseline and at least one post-baseline data.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 249 258
Measure Type: Number
Unit of Measure: participants
83 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments A priori threshold for statistical significance is 0.05.
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Blood Pressure at 12 Week Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a baseline and at least one post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 250 259
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressure (SBP) 1.09  (0.80) -0.72  (0.78)
Diastolic Blood Pressure (DBP) 0.83  (0.51) 0.31  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Change = baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
-0.25 to 3.88
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Change = baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.79 to 1.84
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
13.Secondary Outcome
Title Change From Baseline in Heart Rate at 12 Week Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a baseline and at least one post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 250 259
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
1.76  (0.50) -0.20  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Change = baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
0.67 to 3.26
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
14.Secondary Outcome
Title Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
Hide Description C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide.
Time Frame Baseline through 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 263 267
Measure Type: Number
Unit of Measure: participants
Suicidal Ideation 6 7
Suicidal Behavior 0 0
Suicidal Acts 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.
Method Fisher Exact
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Weight at 12 Week Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a baseline and at least one post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60-120 mg, oral, daily, 12 weeks
oral, daily, 12 weeks
Overall Number of Participants Analyzed 249 259
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
-0.62  (0.15) 0.21  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A priori threshold for statistical significance is 0.05.
Method ANCOVA
Comments Model: Change = baseline + treatment + pooled investigator.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.21 to -0.45
Estimation Comments Least Squares Mean Difference = Duloxetine minus Placebo.
Time Frame These are the adverse events which occurred during the 12 week acute double-blind phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 60-120 mg, oral, daily, 12 weeks oral, daily, 12 weeks
All-Cause Mortality
Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/263 (0.38%)      6/267 (2.25%)    
Cardiac disorders     
Myocardial infarction  1  0/263 (0.00%)  0 1/267 (0.37%)  1
Gastrointestinal disorders     
Pancreatitis  1  0/263 (0.00%)  0 1/267 (0.37%)  1
General disorders     
Chest pain  1  0/263 (0.00%)  0 1/267 (0.37%)  1
Non-cardiac chest pain  1  0/263 (0.00%)  0 1/267 (0.37%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/263 (0.38%)  1 0/267 (0.00%)  0
Muscle spasms  1  0/263 (0.00%)  0 1/267 (0.37%)  1
Psychiatric disorders     
Suicidal ideation  1  0/263 (0.00%)  0 1/267 (0.37%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   217/263 (82.51%)      189/267 (70.79%)    
Gastrointestinal disorders     
Constipation  1  35/263 (13.31%)  35 11/267 (4.12%)  11
Diarrhoea  1  27/263 (10.27%)  30 12/267 (4.49%)  12
Dry mouth  1  31/263 (11.79%)  31 12/267 (4.49%)  12
Nausea  1  83/263 (31.56%)  87 26/267 (9.74%)  28
Vomiting  1  12/263 (4.56%)  15 2/267 (0.75%)  2
General disorders     
Fatigue  1  25/263 (9.51%)  26 19/267 (7.12%)  19
Irritability  2  3/263 (1.14%)  3 12/267 (4.49%)  12
Infections and infestations     
Upper respiratory tract infection  1  13/263 (4.94%)  13 13/267 (4.87%)  14
Metabolism and nutrition disorders     
Decreased appetite  1  13/263 (4.94%)  13 6/267 (2.25%)  6
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  4/263 (1.52%)  4 11/267 (4.12%)  15
Arthralgia  1  3/263 (1.14%)  3 11/267 (4.12%)  11
Nervous system disorders     
Dizziness  1  26/263 (9.89%)  27 14/267 (5.24%)  15
Headache  1  45/263 (17.11%)  48 24/267 (8.99%)  28
Somnolence  1  15/263 (5.70%)  16 9/267 (3.37%)  9
Psychiatric disorders     
Insomnia  1  24/263 (9.13%)  27 19/267 (7.12%)  20
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  23/263 (8.75%)  24 4/267 (1.50%)  4
Vascular disorders     
Hot flush  1  13/263 (4.94%)  14 2/267 (0.75%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00673452     History of Changes
Other Study ID Numbers: 12220
F1J-US-HMGB ( Other Identifier: Eli Lilly and Company )
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: April 14, 2010
Results First Posted: June 24, 2010
Last Update Posted: June 24, 2010