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A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

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ClinicalTrials.gov Identifier: NCT01179672
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : July 14, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 405
Recruitment Details  
Pre-assignment Details Participants tapered off study drug after either completing the 12 weeks of treatment or discontinued treatment early.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper. Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Period Title: Overall Study
Started 203 202
Received at Least 1 Dose of Study Drug 202 202
Entered Taper 181 177
Completed 173 176
Not Completed 30 26
Reason Not Completed
Adverse Event             17             8
Withdrawal by Subject             10             12
Entry Criteria Not Met             0             2
Lost to Follow-up             0             1
Protocol Violation             2             2
Physician Decision             1             1
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description 30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper. Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper. Total of all reporting groups
Overall Number of Baseline Participants 203 202 405
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 202 participants 405 participants
61.56  (9.65) 61.17  (9.42) 61.37  (9.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 202 participants 405 participants
Female
112
  55.2%
111
  55.0%
223
  55.1%
Male
91
  44.8%
91
  45.0%
182
  44.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 202 participants 405 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
203
 100.0%
202
 100.0%
405
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 202 participants 405 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
203
 100.0%
202
 100.0%
405
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 203 participants 202 participants 405 participants
203 202 405
Diabetes Disease Characteristics-Types of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants 202 participants 405 participants
Type I Diabetes 3 3 6
Type II Diabetes 200 199 399
Diabetes Disease Characteristics  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 202 participants 405 participants
Duration of Diabetes 11.53  (6.81) 11.38  (7.47) 11.45  (7.14)
Duration of Diabetic Neuropathy 3.47  (3.91) 3.07  (3.13) 3.27  (3.55)
Duration of Diabetic Neuropathy Pain 3.06  (3.70) 2.59  (2.69) 2.83  (3.24)
Weekly Mean of 24-Hour Average Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
5.72  (1.72) 5.62  (1.66) 5.67  (1.69)
[1]
Measure Description: Participants measured their pain on an 11-point Likert scale that was completed daily. The scale ranged from 0 (no pain) to 10 (worst possible pain). The participant-recorded average pain due to diabetic neuropathy over the previous 24 hours.
Brief Pain Inventory (BPI)-Severity Average Pain in the Last Week   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
5.97  (1.70) 5.86  (1.64) 5.91  (1.67)
[1]
Measure Description: BPI-Severity Modified Short Form Severity was a self-reported scale that measured the severity of pain. Severity scores ranged from 0 (no pain) to 10 (pain as bad as you could imagine). There were 4 questions assessing the severity for worst pain, least pain, average pain, and the pain right now.
Clinical Global Impression of Severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
4.76  (1.22) 4.66  (1.07) 4.71  (1.14)
[1]
Measure Description: Number of participants analyzed was: Duloxetine treatment =126 and Placebo=136. Data from 9 sites were not included in baseline analysis due to wrong questionnaire used. CSI-S was administered by the investigator in the presence of the participant and measured severity of illness at baseline with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Short Form-McGill Pain Questionnaire (SF-MPQ), Sensory Portion Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
12.24  (6.39) 11.81  (5.52) 12.02  (5.97)
[1]
Measure Description: SF-MPQ sensory portion was a self-reported instrument consisting of 11 sensory descriptors describing pain, each rated on an intensity scale from 0 (none) to 3 (severe). Total scores ranged from 0 to 33.
BPI-Interference Average Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
4.38  (2.29) 4.08  (2.30) 4.23  (2.30)
[1]
Measure Description: BPI-Interference Score was self-reported scale that measured interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes).
Sheehan Disability Scale (SDS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 203 participants 202 participants 405 participants
11.16  (7.59) 10.54  (7.31) 10.85  (7.45)
[1]
Measure Description: SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS Total Score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment.
1.Primary Outcome
Title Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
Hide Description 24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 172 173
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.40  (0.14) -1.97  (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 0.030
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.82 to -0.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain
Hide Description 24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 172 173
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Night Pain -2.65  (0.15) -2.11  (0.15)
Worst Pain -2.80  (0.16) -2.25  (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 0.008
Comments P-value is for mean change from baseline to 12-week endpoint in night pain.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.95 to -0.14
Estimation Comments [Not Specified]
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 0.017
Comments P-value is for mean change from baseline to 12 week endpoint in worst pain.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.00 to -0.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale
Hide Description BPI-Severity Scale was a self-reported scale that measured 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). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 175 173
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.50  (0.15) -2.00  (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 0.016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.90 to -0.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale
Hide Description CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 108 118
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.40  (0.10) -1.17  (0.10)
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 0.081
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.48 to 0.03
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint
Hide Description PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline and 12-week PGI-I score.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 173 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.44  (0.07) 2.65  (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 0.034
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.40 to -0.02
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ
Hide Description SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 188 180
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.45  (0.36) -5.33  (0.39)
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 0.022
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment, pooled investigator and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-2.07 to -0.16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain
Hide Description 24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline and postbaseline 24-hour average pain score.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 200 198
Measure Type: Number
Unit of Measure: percentage of participants
≥30% Reduction 61.5 49.0
≥50% Reduction 42.0 28.8
≥75% Reduction 14.5 9.6
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 0.014
Comments P-value is for ≥30% reduction in 24-hour average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test was stratified by pooled investigator.
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 0.006
Comments P-value is for ≥50% reduction in 24-hour average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test was stratified by pooled investigator.
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 0.193
Comments P-value is for ≥75% reduction in 24-hour average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test was stratified by pooled investigator.
8.Secondary Outcome
Title Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score
Hide Description BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline and postbaseline BPI-Severity average pain scores.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 200 197
Measure Type: Number
Unit of Measure: percentage of participants
≥30% Reduction 63.0 46.7
≥50% Reduction 46.0 29.4
≥75% Reduction 15.0 9.6
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 is for ≥30% reduction in 24-hour BPI-Severity average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test was stratified by pooled investigator.
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 is for ≥50% reduction in 24-hour BPI-Severity average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test was stratified by pooled investigator.
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 0.168
Comments P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.
Method Cochran-Mantel-Haenszel
Comments Cochran Mantel Haenszel test was stratified by pooled investigator.
9.Secondary Outcome
Title Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score
Hide Description BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with non-missing BPI-Interference score at baseline and 12 weeks.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 173 176
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.42  (0.13) -1.82  (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 [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-0.96 to -0.24
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score
Hide Description SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
Time Frame Baseline, 12 weeks
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Hide Analysis Population Description
All participants with non-missing SDS Total Score at baseline and 12 weeks.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
Overall Number of Participants Analyzed 172 175
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.36  (0.40) -5.09  (0.42)
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 0.020
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-2.33 to -0.20
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Treatment Placebo Treatment Duloxetine Taper Placebo Taper
Hide Arm/Group Description 30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment; Placebo administered orally, QD for 12 weeks of the treatment. After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper. After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
All-Cause Mortality
Duloxetine Treatment Placebo Treatment Duloxetine Taper Placebo Taper
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Treatment Placebo Treatment Duloxetine Taper Placebo Taper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/202 (1.98%)      3/202 (1.49%)      3/181 (1.66%)      1/177 (0.56%)    
Cardiac disorders         
Coronary artery disease  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Nodal arrhythmia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
General disorders         
Asthenia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis chronic  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 1/177 (0.56%)  1
Metabolism and nutrition disorders         
Diabetes mellitus  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Non-hodgkin's lymphoma  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Nervous system disorders         
Cerebral infarction  1  0/202 (0.00%)  0 0/202 (0.00%)  0 1/181 (0.55%)  1 0/177 (0.00%)  0
Diabetic neuropathy  1  2/202 (0.99%)  2 0/202 (0.00%)  0 2/181 (1.10%)  2 0/177 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine Treatment Placebo Treatment Duloxetine Taper Placebo Taper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/202 (46.04%)      71/202 (35.15%)      8/181 (4.42%)      5/177 (2.82%)    
Blood and lymphatic system disorders         
Anaemia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 1/177 (0.56%)  1
Leukopenia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Neutropenia  1  0/202 (0.00%)  0 0/202 (0.00%)  0 1/181 (0.55%)  1 0/177 (0.00%)  0
Cardiac disorders         
Coronary artery disease  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Palpitations  1  5/202 (2.48%)  5 4/202 (1.98%)  4 0/181 (0.00%)  0 0/177 (0.00%)  0
Ear and labyrinth disorders         
Hypoacusis  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Tinnitus  1  1/202 (0.50%)  1 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Vertigo  1  2/202 (0.99%)  2 3/202 (1.49%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Eye disorders         
Amaurosis  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Diabetic retinopathy  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Photophobia  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Vision blurred  1  3/202 (1.49%)  3 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Visual impairment  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  7/202 (3.47%)  7 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Abdominal distension  1  1/202 (0.50%)  1 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Abdominal pain  1  2/202 (0.99%)  2 3/202 (1.49%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Abdominal pain upper  1  3/202 (1.49%)  3 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Constipation  1  10/202 (4.95%)  10 4/202 (1.98%)  4 0/181 (0.00%)  0 0/177 (0.00%)  0
Diarrhoea  1  2/202 (0.99%)  2 3/202 (1.49%)  3 1/181 (0.55%)  1 0/177 (0.00%)  0
Dry mouth  1  5/202 (2.48%)  5 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Dyspepsia  1  5/202 (2.48%)  5 4/202 (1.98%)  4 0/181 (0.00%)  0 0/177 (0.00%)  0
Epigastric discomfort  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Eructation  1  1/202 (0.50%)  1 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Faeces hard  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Gastric ulcer  1  0/202 (0.00%)  0 0/202 (0.00%)  0 0/181 (0.00%)  0 1/177 (0.56%)  1
Gastritis  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Gastrointestinal disorder  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Hiatus hernia  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hypoaesthesia oral  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Infrequent bowel movements  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Nausea  1  21/202 (10.40%)  23 7/202 (3.47%)  7 1/181 (0.55%)  1 0/177 (0.00%)  0
Regurgitation  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Tongue discolouration  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Toothache  1  0/202 (0.00%)  0 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Vomiting  1  3/202 (1.49%)  3 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
General disorders         
Asthenia  1  9/202 (4.46%)  10 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Chest discomfort  1  0/202 (0.00%)  0 4/202 (1.98%)  4 0/181 (0.00%)  0 0/177 (0.00%)  0
Chest pain  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Chills  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Fatigue  1  10/202 (4.95%)  10 4/202 (1.98%)  6 0/181 (0.00%)  0 0/177 (0.00%)  0
Hunger  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Malaise  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Oedema peripheral  1  2/202 (0.99%)  2 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Sluggishness  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Thirst  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Hepatobiliary disorders         
Fatty liver alcoholic  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hepatic function abnormal  1  2/202 (0.99%)  2 1/202 (0.50%)  1 0/181 (0.00%)  0 1/177 (0.56%)  1
Hepatic lesion  1  1/202 (0.50%)  1 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Liver injury  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Infections and infestations         
Influenza  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Nasopharyngitis  1  4/202 (1.98%)  4 2/202 (0.99%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Upper respiratory tract infection  1  1/202 (0.50%)  1 3/202 (1.49%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Urinary tract infection  1  0/202 (0.00%)  0 3/202 (1.49%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Injury, poisoning and procedural complications         
Head injury  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Joint dislocation  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Spinal cord injury cauda equina  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood alkaline phosphatase increased  1  0/202 (0.00%)  0 0/202 (0.00%)  0 1/181 (0.55%)  1 0/177 (0.00%)  0
Blood bicarbonate decreased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood cholesterol decreased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood creatine phosphokinase increased  1  2/202 (0.99%)  2 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood potassium decreased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood potassium increased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood pressure increased  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood triglycerides increased  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Blood uric acid increased  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Gamma-glutamyltransferase increased  1  2/202 (0.99%)  2 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Transaminases increased  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Weight increased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
White blood cell count decreased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 1/181 (0.55%)  1 0/177 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  11/202 (5.45%)  11 8/202 (3.96%)  8 0/181 (0.00%)  0 0/177 (0.00%)  0
Dyslipidaemia  1  1/202 (0.50%)  1 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Hypercalcaemia  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hypercholesterolaemia  1  2/202 (0.99%)  2 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Hyperkalaemia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Hyperlipidaemia  1  9/202 (4.46%)  9 5/202 (2.48%)  5 1/181 (0.55%)  1 0/177 (0.00%)  0
Hypertriglyceridaemia  1  3/202 (1.49%)  3 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hyperuricaemia  1  1/202 (0.50%)  1 1/202 (0.50%)  1 2/181 (1.10%)  2 1/177 (0.56%)  1
Hypoglycaemia  1  1/202 (0.50%)  2 3/202 (1.49%)  3 1/181 (0.55%)  1 0/177 (0.00%)  0
Hypokalaemia  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Back pain  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Fasciitis  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Myalgia  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Osteoporosis  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Pain in extremity  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Nervous system disorders         
Autonomic neuropathy  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Cerebral infarction  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Clonus  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Convulsion  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Diabetic autonomic neuropathy  1  1/202 (0.50%)  1 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Disturbance in attention  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Dizziness  1  17/202 (8.42%)  18 9/202 (4.46%)  9 0/181 (0.00%)  0 0/177 (0.00%)  0
Dreamy state  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Dysgeusia  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Formication  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Headache  1  6/202 (2.97%)  6 3/202 (1.49%)  4 1/181 (0.55%)  1 1/177 (0.56%)  1
Hypersomnia  1  2/202 (0.99%)  2 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hypoaesthesia  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Lacunar infarction  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Lethargy  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Memory impairment  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Poor quality sleep  1  3/202 (1.49%)  3 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Sciatica  1  0/202 (0.00%)  0 0/202 (0.00%)  0 1/181 (0.55%)  1 0/177 (0.00%)  0
Somnolence  1  17/202 (8.42%)  18 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Tremor  1  3/202 (1.49%)  3 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Psychiatric disorders         
Agitation  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Anxiety  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Dysphoria  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Fear  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Food aversion  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Illusion  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Insomnia  1  3/202 (1.49%)  3 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Mutism  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Nervousness  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Nightmare  1  0/202 (0.00%)  0 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Panic attack  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Sleep disorder  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Tic  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Renal and urinary disorders         
Dysuria  1  4/202 (1.98%)  4 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Nephrolithiasis  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Pollakiuria  1  2/202 (0.99%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Renal failure chronic  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Urinary retention  1  1/202 (0.50%)  2 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Urine flow decreased  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  1/91 (1.10%)  1 0/91 (0.00%)  0 0/85 (0.00%)  0 0/76 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/202 (0.50%)  1 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Dry throat  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Dyspnoea  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis allergic  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Diabetic foot  1  0/202 (0.00%)  0 0/202 (0.00%)  0 0/181 (0.00%)  0 1/177 (0.56%)  1
Eczema  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Erythema  1  1/202 (0.50%)  2 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Hyperhidrosis  1  8/202 (3.96%)  8 3/202 (1.49%)  3 0/181 (0.00%)  0 0/177 (0.00%)  0
Night sweats  1  1/202 (0.50%)  1 0/202 (0.00%)  0 0/181 (0.00%)  0 0/177 (0.00%)  0
Pruritus  1  2/202 (0.99%)  2 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Rash  1  2/202 (0.99%)  2 2/202 (0.99%)  2 0/181 (0.00%)  0 0/177 (0.00%)  0
Skin swelling  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Surgical and medical procedures         
Haemorrhoid operation  1  0/202 (0.00%)  0 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Vascular disorders         
Hypertension  1  1/202 (0.50%)  1 1/202 (0.50%)  1 0/181 (0.00%)  0 0/177 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01179672     History of Changes
Other Study ID Numbers: 13649
F1J-MC-HMGV ( Other Identifier: Eli Lilly and Company )
First Submitted: August 10, 2010
First Posted: August 11, 2010
Results First Submitted: June 12, 2014
Results First Posted: July 14, 2014
Last Update Posted: October 13, 2014