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A Study in Depression and Associated Painful Physical Symptoms

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: NCT01070329
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : February 13, 2012
Last Update Posted : February 13, 2012
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 Major Depressive Disorder
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 527
Recruitment Details  
Pre-assignment Details

Double-blind treatment phase: Participants randomly assigned to duloxetine received 30 mg once daily (QD) for 1 week, followed by 60 mg QD for 7 weeks. Participants randomly assigned to placebo received placebo QD for 8 weeks.

Taper phase: Duloxetine group: 30 mg QD for 2 weeks. Placebo group: QD for 2 weeks.

Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. Participants received placebo QD, po for 8 weeks.
Period Title: Overall Study
Started 261 266
Completed 209 217
Not Completed 52 49
Reason Not Completed
Adverse Event             13             10
Lost to Follow-up             22             12
Withdrawal by Subject             9             11
Protocol Violation             3             8
Lack of Efficacy             2             6
Physician Decision             2             1
Entry Criteria Not Met             1             0
Sponsor Decision             0             1
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. Participants received placebo QD, po for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 261 266 527
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 266 participants 527 participants
45.15  (12.47) 44.21  (12.38) 44.68  (12.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 266 participants 527 participants
Female
183
  70.1%
178
  66.9%
361
  68.5%
Male
78
  29.9%
88
  33.1%
166
  31.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 266 participants 527 participants
Hispanic or Latino
38
  14.6%
32
  12.0%
70
  13.3%
Not Hispanic or Latino
223
  85.4%
234
  88.0%
457
  86.7%
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 261 participants 266 participants 527 participants
American Indian or Alaska Native
4
   1.5%
2
   0.8%
6
   1.1%
Asian
4
   1.5%
5
   1.9%
9
   1.7%
Native Hawaiian or Other Pacific Islander
2
   0.8%
0
   0.0%
2
   0.4%
Black or African American
64
  24.5%
66
  24.8%
130
  24.7%
White
184
  70.5%
190
  71.4%
374
  71.0%
More than one race
3
   1.1%
3
   1.1%
6
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 261 participants 266 participants 527 participants
United States 242 248 490
Puerto Rico 19 18 37
Brief Pain Inventory Severity: Worst Pain Score (BPI-S: Worst Pain)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
7.06  (1.67) 6.88  (1.67) 6.97  (1.67)
[1]
Measure Description: The BPI-S: Worst Pain is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Brief Pain Inventory Severity: Least Pain Score (BPI-S: Least Pain)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
4.25  (1.99) 4.11  (1.97) 4.18  (1.98)
[1]
Measure Description: The BPI-S: Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Brief Pain Inventory Severity: Average Pain Score (BPI-S: Average Pain)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
5.78  (1.64) 5.63  (1.69) 5.70  (1.66)
[1]
Measure Description: The BPI-S: Average Pain is a self-reported scale that measures 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).
Brief Pain Inventory Severity: Pain Right Now Score (BPI-S: Pain Right Now)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
5.41  (2.13) 5.26  (2.18) 5.34  (2.16)
[1]
Measure Description: The BPI-S: Pain Right Now is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Brief Pain Inventory - Interference (BPI-I)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
6.04  (2.03) 5.98  (1.97) 6.01  (2.00)
[1]
Measure Description: The BPI-I 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.
Clinical Global Impressions of Severity Scale (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
4.39  (0.56) 4.38  (0.53) 4.39  (0.54)
[1]
Measure Description: The CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
30.06  (4.72) 29.84  (4.82) 29.95  (4.76)
[1]
Measure Description: The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Sheehan Disability Scale-Item 1 (SDS-Item 1), N=187, 193, 380   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
5.97  (2.06) 6.22  (2.04) 6.10  (2.05)
[1]
Measure Description: The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
Sheehan Disability Scale-Item 2 (SDS-Item 2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
6.51  (2.20) 6.30  (2.11) 6.40  (2.16)
[1]
Measure Description: The SDS is completed by the participant and Item 2 is used to assess the effect of the participant's symptoms on their social life/leisure activities. Scores range from 0 to 10 with higher values indicating greater disruption in the patient's social life.
Sheehan Disability Scale-Item 3 (SDS-Item 3)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
6.41  (2.17) 6.31  (2.05) 6.36  (2.11)
[1]
Measure Description: The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
Sheehan Disability Scale -Total Score (SDS Total)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 261 participants 266 participants 527 participants
19.16  (6.02) 18.88  (5.70) 19.02  (5.86)
[1]
Measure Description: The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Number of Previous Major Depressive Disorder (MDD) Episodes  
Mean (Standard Deviation)
Unit of measure:  Number of previous episodes
Number Analyzed 261 participants 266 participants 527 participants
3.58  (3.34) 3.65  (3.42) 3.61  (3.38)
1.Primary Outcome
Title Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
Hide Description A self-reported scale that measures 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). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Day 1 through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.66  (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 <0.001
Comments The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.75 to -0.22
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
Hide Description The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.96  (0.58) -10.77  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for statistical significance is 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.20
Confidence Interval (2-Sided) 95%
-5.77 to -2.62
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
Hide Description SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Disrupt Work/School Work (N=178, 188) -3.01  (0.19) -2.06  (0.19)
Disrupt Social Life/Leisure Activities -3.14  (0.17) -2.17  (0.16)
Disrupt Family/Home Responsibilities -3.04  (0.17) -2.09  (0.17)
SDS Total Score -9.16  (0.47) -6.28  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.47 to -0.42
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 <0.001
Comments This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.42 to -0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.41 to -0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p>0.05).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.88
Confidence Interval (2-Sided) 95%
-4.16 to -1.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
Hide Description The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.
Time Frame Baseline, up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result, Last Observation Carried Forward (LOCF).
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Measure Type: Number
Unit of Measure: percentage of participants
37.3 23.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving Remission up to Week 8
Hide Description The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Measure Type: Number
Unit of Measure: percentage of participants
15.7 11.7
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 0.173
Comments This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
Hide Description The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.48  (0.49) -8.67  (0.48)
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 [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p>0.05).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.81
Confidence Interval (2-Sided) 95%
-4.13 to -1.48
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
Hide Description The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Baseline, 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.60  (0.41) -6.52  (0.40)
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 [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p>0.05).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-3.18 to -0.96
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8
Hide Description Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
BPI Severity for Worst Pain -1.88  (0.11) -1.32  (0.11)
BPI Severity for Least Pain -1.18  (0.10) -0.80  (0.10)
BPI Severity for Average Pain -1.66  (0.10) -1.17  (0.10)
BPI Severity for Pain Right Now -1.82  (0.11) -1.25  (0.11)
BPI Pain Interference with General Activity -1.87  (0.12) -1.44  (0.12)
BPI Pain Interference with Mood -2.25  (0.12) -1.77  (0.12)
BPI Pain Interference with Walking Ability -1.62  (0.11) -1.20  (0.11)
BPI Pain Interference with Normal Work -1.88  (0.12) -1.47  (0.12)
BPI Pain Interference with Relations With Others -1.90  (0.13) -1.53  (0.12)
BPI Pain Interference with Sleep -2.13  (0.14) -1.74  (0.14)
BPI Pain Interference with Enjoyment of Life -2.32  (0.13) -1.84  (0.13)
BPI Mean Pain Interference Score -2.03  (0.11) -1.58  (0.11)
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 This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.85 to -0.27
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 0.003
Comments This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.64 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.75 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.86 to -0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
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%
-0.75 to -0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.80 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.72 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.72 to -0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.70 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.75 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.81 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.74 to -0.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I) Score at Week 8
Hide Description A scale that measures the participant'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). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.48  (0.08) 3.17  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-0.90 to -0.49
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
Hide Description The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a "yes" answer to actual attempt or completed suicide.
Time Frame Baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline C-SSRS result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Measure Type: Number
Unit of Measure: participants
Suicidal Ideation 21 34
Suicidal Behavior 2 0
Suicidal Acts 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Fisher Exact
Comments [Not Specified]
11.Other Pre-specified Outcome
Title Change From Baseline in Pulse Rate up to Week 8
Hide Description

The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.

The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.

Time Frame Baseline, up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.

Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF).

Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
Change from Baseline in Pulse Rate at Week 8 2.08  (0.62) 0.40  (0.60)
Change from Baseline in Pulse Rate up to Week 8 2.01  (0.57) 0.62  (0.57)
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 0.050
Comments This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.00 to 3.34
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 0.071
Comments This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
-0.12 to 2.90
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8
Hide Description

The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.

The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.

Time Frame Baseline, up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.

Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF).

Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Change from Baseline in SBP at Week 8 0.82  (0.71) -1.09  (0.70)
Change from Baseline in DBP at Week 8 1.88  (0.48) 0.08  (0.47)
Change from Baseline in SBP up to Week 8 0.56  (0.68) -1.14  (0.67)
Change from Baseline in DBP up to Week 8 1.86  (0.46) 0.05  (0.45)
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 0.050
Comments This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
0.00 to 3.82
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 0.007
Comments This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
0.50 to 3.10
Estimation Comments [Not Specified]
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 0.063
Comments This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
-0.09 to 3.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
0.60 to 3.02
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change From Baseline in Weight up to Week 8
Hide Description

The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.

The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline.

Time Frame Baseline, up to week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.

Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF).

Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 255 265
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
Change from Baseline in Weight at Week 8 -0.69  (0.14) -0.15  (0.14)
Change from Baseline in Weight up to Week 8 -0.66  (0.14) -0.09  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
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%
-0.93 to -0.15
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 0.002
Comments This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.93 to -0.22
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine
Hide Description Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high).
Time Frame Baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks.
Overall Number of Participants Analyzed 215 229
Measure Type: Number
Unit of Measure: participants
1 9
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 0.021
Comments P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. Participants received placebo QD, po for 8 weeks.
All-Cause Mortality
Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/261 (0.38%)      3/266 (1.13%)    
General disorders     
Non-cardiac chest pain  1  1/261 (0.38%)  1 0/266 (0.00%)  0
Infections and infestations     
Gangrene  1  0/261 (0.00%)  0 1/266 (0.38%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/261 (0.00%)  0 1/266 (0.38%)  1
Psychiatric disorders     
Suicidal ideation  1  0/261 (0.00%)  0 1/266 (0.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/261 (65.13%)      135/266 (50.75%)    
Gastrointestinal disorders     
Constipation  1  12/261 (4.60%)  12 11/266 (4.14%)  11
Diarrhoea  1  18/261 (6.90%)  18 7/266 (2.63%)  7
Dry mouth  1  30/261 (11.49%)  30 22/266 (8.27%)  22
Dyspepsia  1  7/261 (2.68%)  7 8/266 (3.01%)  8
Nausea  1  46/261 (17.62%)  48 22/266 (8.27%)  22
General disorders     
Fatigue  1  7/261 (2.68%)  7 5/266 (1.88%)  5
Infections and infestations     
Nasopharyngitis  1  3/261 (1.15%)  3 6/266 (2.26%)  6
Metabolism and nutrition disorders     
Decreased appetite  1  10/261 (3.83%)  11 2/266 (0.75%)  2
Nervous system disorders     
Dizziness  1  17/261 (6.51%)  18 12/266 (4.51%)  13
Headache  1  23/261 (8.81%)  25 24/266 (9.02%)  25
Somnolence  1  22/261 (8.43%)  22 9/266 (3.38%)  9
Psychiatric disorders     
Depression  1  0/261 (0.00%)  0 6/266 (2.26%)  6
Insomnia  1  14/261 (5.36%)  16 7/266 (2.63%)  7
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  8/261 (3.07%)  8 0/266 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT01070329     History of Changes
Other Study ID Numbers: 13630
F1J-US-HMGU ( Other Identifier: Eli Lilly and Company )
First Submitted: February 16, 2010
First Posted: February 18, 2010
Results First Submitted: January 10, 2012
Results First Posted: February 13, 2012
Last Update Posted: February 13, 2012