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Trial record 67 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

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: NCT00552175
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : April 13, 2010
Last Update Posted : April 13, 2010
Sponsor:
Collaborator:
Shionogi
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 Diabetic Neuropathies
Interventions Drug: Duloxetine hydrochloride - 40 mg
Drug: placebo
Drug: Duloxetine hydrochloride - 60 mg
Enrollment 339
Recruitment Details  
Pre-assignment Details Full Analysis Set Population consisted of all randomized patients who had at least one post-baseline measure of the primary efficacy variable.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description placebo comparator taken orally every day Duloxetine 40 milligrams (mg) taken orally every day Duloxetine 60 milligrams (mg) taken orally every day
Period Title: Overall Study
Started 167 86 86
Full Analysis Set Population 167 85 86
Completed 150 73 72
Not Completed 17 13 14
Reason Not Completed
Lack of Efficacy             2             0             1
Adverse Event             9             9             10
Withdrawal by Subject             2             2             1
Lost to Follow-up             0             0             1
Entry Criteria Not Met             1             1             0
Reason Not Specified             3             1             1
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg Total
Hide Arm/Group Description placebo comparator taken orally every day Duloxetine 40 milligrams (mg) taken orally every day Duloxetine 60 milligrams (mg) taken orally every day Total of all reporting groups
Overall Number of Baseline Participants 167 85 86 338
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 85 participants 86 participants 338 participants
60.8  (9.2) 62.1  (9.3) 59.7  (12.1) 60.8  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 85 participants 86 participants 338 participants
Female
38
  22.8%
20
  23.5%
24
  27.9%
82
  24.3%
Male
129
  77.2%
65
  76.5%
62
  72.1%
256
  75.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 167 participants 85 participants 86 participants 338 participants
167 85 86 338
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 167 participants 85 participants 86 participants 338 participants
167 85 86 338
Duration of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 85 participants 86 participants 338 participants
<5 years 33 20 16 69
5 - 10 years 32 18 14 64
>= 10 years 97 47 56 200
Unknown 5 0 0 5
Type of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 85 participants 86 participants 338 participants
Type I 8 5 4 17
Type II 159 80 82 321
Beck Depression Inventory-II (BDI-II)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 167 participants 85 participants 86 participants 338 participants
8.8  (6.8) 9.4  (8.8) 9.4  (7.2) 9.1  (7.4)
[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 ranges from 0 (no depression) to 63 (severe depression).
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/square meters (kg/m^2)
Number Analyzed 167 participants 85 participants 86 participants 338 participants
23.90  (3.70) 23.27  (3.67) 24.20  (3.50) 23.82  (3.65)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Brief Pain Inventory (BPI) Interference Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 167 participants 85 participants 86 participants 338 participants
General Activity 4.4  (2.4) 4.5  (2.7) 4.5  (2.4) 4.5  (2.5)
Mood 4.2  (2.4) 3.9  (2.5) 4.2  (2.5) 4.1  (2.5)
Walking Ability 4.0  (2.6) 4.4  (2.8) 4.3  (2.5) 4.2  (2.6)
Normal Work 3.7  (2.7) 3.9  (2.6) 4.3  (2.5) 3.9  (2.6)
Relation to People 2.6  (2.5) 2.7  (2.7) 2.9  (2.4) 2.7  (2.5)
Sleep 3.9  (2.7) 4.0  (2.8) 4.3  (2.7) 4.0  (2.7)
Enjoyment of Life 3.5  (2.5) 3.7  (2.7) 4.0  (2.5) 3.7  (2.6)
Average of Interference Scores 3.75  (2.15) 3.88  (2.25) 4.09  (2.13) 3.87  (2.17)
[1]
Measure 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. Each question has total scores ranging from 0 to 10.
Brief Pain Inventory (BPI) Severity Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 167 participants 85 participants 86 participants 338 participants
Worst Pain 6.7  (1.4) 6.5  (1.4) 6.6  (1.5) 6.6  (1.4)
Least Pain 4.1  (1.8) 4.0  (1.8) 4.2  (1.6) 4.1  (1.8)
Average Pain 5.6  (1.3) 5.6  (1.3) 5.7  (1.3) 5.6  (1.3)
Pain Right Now 5.1  (1.7) 5.2  (1.8) 5.3  (1.4) 5.2  (1.7)
[1]
Measure Description: A self-reported scale that measures the severity of pain and the interference of pain on function. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.
Duration of Diabetic Neuropathy  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 85 participants 86 participants 338 participants
4.21  (4.44) 4.58  (3.90) 4.16  (3.67) 4.29  (4.11)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 167 participants 85 participants 86 participants 338 participants
164.13  (8.65) 163.63  (8.78) 164.02  (7.32) 163.98  (8.34)
Weekly Means of 24-Hour Average Pain, Worst Pain, and Night Pain Diary Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 167 participants 85 participants 86 participants 338 participants
Average Pain Score 5.78  (1.17) 5.79  (1.23) 5.76  (1.17) 5.78  (1.18)
Worst Pain Score 6.66  (1.25) 6.54  (1.33) 6.61  (1.33) 6.62  (1.29)
Night Pain Score 5.5  (1.49) 5.55  (1.64) 5.69  (1.54) 5.56  (1.54)
[1]
Measure Description: 24-hour average pain severity scores recorded in a diary daily on an 11-point numerical rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point numerical rating scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Total scores for each pain assessment (average, worst, night) range from 0 to 10.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 167 participants 85 participants 86 participants 338 participants
64.52  (11.93) 62.72  (13.35) 65.08  (10.23) 64.21  (11.9)
1.Primary Outcome
Title Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Hide Description Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 167 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.61  (0.18) -2.47  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.17 to -0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
2.Secondary Outcome
Title Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries
Hide Description Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 167 85 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.61  (0.19) -2.41  (0.21) -2.53  (0.21)
3.Secondary Outcome
Title Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Hide Description Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 167 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.55  (0.19) -2.51  (0.19)
Night Pain -1.56  (0.19) -2.39  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Worst Pain.
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.27 to -0.64
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Night Pain.
Method Mixed Models Analysis
Comments Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.15 to -0.51
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
4.Secondary Outcome
Title Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
Hide Description Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 167 85 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.55  (0.19) -2.42  (0.22) -2.59  (0.22)
Night Pain -1.56  (0.19) -2.33  (0.22) -2.45  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Worst Pain analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.26 to -0.49
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Worst Pain analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-1.43 to -0.66
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Night Pain analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.17 to -0.39
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Night Pain analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.28 to -0.5
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
5.Secondary Outcome
Title Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)
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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 165 169
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.18  (0.12) 2.53  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.85 to -0.44
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
6.Secondary Outcome
Title Patient Global Impression of Improvement Scale at Week 12
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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 165 84 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.18  (0.12) 2.53  (0.14) 2.52  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.9 to -0.39
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.91 to -0.4
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
7.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Hide Description A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 165 169
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.62  (0.21) -2.59  (0.21)
Least Pain -1.13  (0.21) -1.98  (0.21)
Average Pain -1.54  (0.2) -2.54  (0.2)
Pain Right Now -1.67  (0.22) -2.59  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Worst Pain.
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-1.34 to -0.61
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Least Pain.
Method Mixed Models Analysis
Comments Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.21 to -0.48
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Average Pain.
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-1.33 to -0.67
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Pain Right Now.
Method Mixed Models Analysis
Comments Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.29 to -0.54
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
8.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
Hide Description A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 165 84 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.62  (0.21) -2.51  (0.25) -2.68  (0.25)
Least Pain -1.13  (0.21) -1.92  (0.25) -2.04  (0.25)
Average Pain -1.55  (0.2) -2.53  (0.23) -2.56  (0.23)
Pain Right Now -1.67  (0.22) -2.55  (0.25) -2.62  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Worst Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.34 to -0.44
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Worst Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.51 to -0.62
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Least Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.23 to -0.33
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Least Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Mean Squares Difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.36 to -0.46
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Average Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-1.39 to -0.58
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Average Pain Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-1.41 to -0.61
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Pain Right Now Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.35 to -0.41
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Pain Right Now Score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.41 to -0.48
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
9.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
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. Each question has a total range of scores from 0 to 10.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 165 169
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
General Activity -1.88  (0.24) -2.29  (0.24)
Mood -1.91  (0.24) -2.28  (0.24)
Walking Ability -1.82  (0.23) -2.31  (0.23)
Normal Work -1.49  (0.23) -1.86  (0.23)
Relation to People -0.77  (0.23) -1.32  (0.23)
Sleep -1.69  (0.24) -2.15  (0.24)
Enjoyment of Life -1.59  (0.23) -2.15  (0.23)
Average of Interference Scores -1.56  (0.2) -2.04  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0676
Comments P-value for General Activity.
Method Mixed Models Analysis
Comments Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.85 to 0.03
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0933
Comments P-value for Mood.
Method Mixed Models Analysis
Comments Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.8 to 0.06
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments P-value for Walking Ability.
Method Mixed Models Analysis
Comments Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.91 to -0.07
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0783
Comments P-value for Normal Work.
Method Mixed Models Analysis
Comments Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.8 to 0.04
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments P-value for Relation to People.
Method Mixed Models Analysis
Comments Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.96 to -0.15
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0378
Comments P-value for Sleep.
Method Mixed Models Analysis
Comments Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.9 to -0.03
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments P-value for Enjoyment of Life.
Method Mixed Models Analysis
Comments Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.98 to -0.14
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments P-value for Average of Interference Scores
Method Mixed Models Analysis
Comments Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.85 to -0.12
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
10.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
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. Each question has a total range of scores from 0 to 10.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 165 84 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
General Activity -1.88  (0.24) -2.48  (0.29) -2.1  (0.29)
Mood -1.91  (0.24) -2.18  (0.29) -2.39  (0.29)
Walking Ability -1.82  (0.23) -2.32  (0.28) -2.31  (0.28)
Normal Work -1.49  (0.23) -1.84  (0.28) -1.9  (0.28)
Relation to People -0.77  (0.23) -1.16  (0.27) -1.49  (0.27)
Sleep -1.69  (0.24) -2.26  (0.29) -2.05  (0.29)
Enjoyment of Life -1.59  (0.23) -1.96  (0.28) -2.35  (0.28)
Average of Interference Scores -1.56  (0.2) -2  (0.24) -2.08  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments General Activity score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.14 to -0.06
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments General Activity score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.77 to 0.32
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Mood score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.8 to 0.27
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Mood score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.01 to 0.05
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Walking Ability score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.02 to 0.02
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Walking Ability score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.01 to 0.03
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Normal Work score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.86 to 0.16
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Normal Work score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.92 to 0.11
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Relation to People score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.89 to 0.11
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Relation to People score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.21 to -0.22
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Sleep score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.11 to -0.03
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Sleep score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.9 to 0.18
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Enjoyment of Life score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.88 to 0.15
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Enjoyment of Life score analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.27 to -0.24
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments Average of Interference scores analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.9 to 0
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments Average of Interference scores analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.97 to -0.07
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
11.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Hide 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 ranges from 0 (no depression) to 63 (severe depression).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg and 60 mg Combined
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
Overall Number of Participants Analyzed 165 169
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.27  (0.64) -3.37  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg and 60 mg Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8517
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-1.22 to 1.01
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
12.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12
Hide 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 ranges from 0 (no depression) to 63 (severe depression).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
placebo comparator taken orally every day
Duloxetine 40 milligrams (mg) taken orally every day
Duloxetine 60 milligrams (mg) taken orally every day
Overall Number of Participants Analyzed 165 84 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.28  (0.65) -2.94  (0.76) -3.83  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-1.03 to 1.71
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.92 to 0.81
Estimation Comments Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description placebo comparator taken orally every day Duloxetine 40 milligrams (mg) taken orally every day Duloxetine 60 milligrams (mg) taken orally every day
All-Cause Mortality
Placebo Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/167 (3.59%)      3/85 (3.53%)      2/86 (2.33%)    
Hepatobiliary disorders       
Hepatic function abnormal  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Infections and infestations       
Arthritis bacterial  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Epiglottitis  1  0/167 (0.00%)  0 0/85 (0.00%)  0 1/86 (1.16%)  1
Osteomyelitis  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Sepsis  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Tuberculous pleurisy  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Injury, poisoning and procedural complications       
Alcohol poisoning  1  0/167 (0.00%)  0 1/85 (1.18%)  1 0/86 (0.00%)  0
Back injury  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Contusion  1  0/167 (0.00%)  0 1/85 (1.18%)  1 0/86 (0.00%)  0
Ulna fracture  1  0/167 (0.00%)  0 1/85 (1.18%)  1 0/86 (0.00%)  0
Investigations       
Blood alkaline phosphatase increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Blood bilirubin increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
C-reactive protein increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Platelet count increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Urine albumin/creatinine ratio increased  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/167 (0.00%)  0 1/85 (1.18%)  1 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pathological fracture  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Nervous system disorders       
Cerebral infarction  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Facial palsy  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Hemiparesis  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Radiculopathy  1  0/167 (0.00%)  0 0/85 (0.00%)  0 1/86 (1.16%)  1
Thalamus haemorrhage  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Psychiatric disorders       
Self injurious behaviour  1  0/167 (0.00%)  0 0/85 (0.00%)  0 1/86 (1.16%)  1
Renal and urinary disorders       
Renal failure acute  1  1/167 (0.60%)  1 0/85 (0.00%)  0 0/86 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   121/167 (72.46%)      71/85 (83.53%)      73/86 (84.88%)    
Ear and labyrinth disorders       
Tinnitus  1  0/167 (0.00%)  0 4/85 (4.71%)  4 1/86 (1.16%)  1
Gastrointestinal disorders       
Constipation  1  9/167 (5.39%)  9 6/85 (7.06%)  6 5/86 (5.81%)  6
Diarrhoea  1  6/167 (3.59%)  6 4/85 (4.71%)  5 7/86 (8.14%)  7
Nausea  1  3/167 (1.80%)  3 10/85 (11.76%)  11 14/86 (16.28%)  17
Stomach discomfort  1  4/167 (2.40%)  4 3/85 (3.53%)  4 4/86 (4.65%)  4
Vomiting  1  2/167 (1.20%)  2 4/85 (4.71%)  5 5/86 (5.81%)  7
General disorders       
Malaise  1  3/167 (1.80%)  3 3/85 (3.53%)  3 6/86 (6.98%)  7
Thirst  1  3/167 (1.80%)  3 4/85 (4.71%)  4 4/86 (4.65%)  4
Infections and infestations       
Nasopharyngitis  1  24/167 (14.37%)  24 10/85 (11.76%)  11 14/86 (16.28%)  16
Investigations       
Alanine aminotransferase increased  1  6/167 (3.59%)  6 5/85 (5.88%)  5 5/86 (5.81%)  5
Aspartate aminotransferase increased  1  6/167 (3.59%)  6 5/85 (5.88%)  5 8/86 (9.30%)  8
Blood alkaline phosphatase increased  1  1/167 (0.60%)  1 4/85 (4.71%)  4 2/86 (2.33%)  2
Blood creatine phosphokinase increased  1  6/167 (3.59%)  6 6/85 (7.06%)  6 0/86 (0.00%)  0
Blood glucose decreased  1  7/167 (4.19%)  15 2/85 (2.35%)  4 2/86 (2.33%)  2
Blood lactate dehydrogenase increased  1  4/167 (2.40%)  4 2/85 (2.35%)  2 5/86 (5.81%)  5
Gamma-glutamyltransferase increased  1  4/167 (2.40%)  4 2/85 (2.35%)  2 5/86 (5.81%)  5
Glycosylated haemoglobin increased  1  4/167 (2.40%)  4 1/85 (1.18%)  1 5/86 (5.81%)  5
White blood cell count increased  1  4/167 (2.40%)  4 4/85 (4.71%)  4 5/86 (5.81%)  5
Metabolism and nutrition disorders       
Decreased appetite  1  0/167 (0.00%)  0 1/85 (1.18%)  1 4/86 (4.65%)  4
Nervous system disorders       
Dizziness  1  2/167 (1.20%)  3 6/85 (7.06%)  8 4/86 (4.65%)  4
Headache  1  6/167 (3.59%)  9 4/85 (4.71%)  4 2/86 (2.33%)  3
Somnolence  1  14/167 (8.38%)  14 16/85 (18.82%)  16 21/86 (24.42%)  23
Skin and subcutaneous tissue disorders       
Eczema  1  5/167 (2.99%)  5 4/85 (4.71%)  4 1/86 (1.16%)  1
Vascular disorders       
Orthostatic hypotension  1  1/167 (0.60%)  1 1/85 (1.18%)  1 4/86 (4.65%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
The protocol-specified primary analyses for this study were comparisons between combined duloxetine arms (40 mg + 60 mg) and placebo. The study was powered on combined duloxetine arms and statistical comparisons were not performed among single arms.
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: NCT00552175     History of Changes
Other Study ID Numbers: 12191
0715N0831 ( Other Identifier: Shionogi & Co., Ltd )
F1J-JE-HMFX ( Other Identifier: Eli Lilly and Company )
First Submitted: October 31, 2007
First Posted: November 1, 2007
Results First Submitted: March 26, 2010
Results First Posted: April 13, 2010
Last Update Posted: April 13, 2010