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Trial record 21 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study of Duloxetine in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01552057
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : December 19, 2014
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Shionogi
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 Fibromyalgia
Interventions Drug: Duloxetine 60 mg
Drug: Placebo
Enrollment 393
Recruitment Details  
Pre-assignment Details Randomized participants who completed the 14-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 1-week taper and were observed 1 week post-treatment for safety.
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description

Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).

During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.

During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.

Period Title: Overall Study
Started 196 197
Received at Least 1 Dose of Study Drug 194 196
Completed 166 149
Not Completed 30 48
Reason Not Completed
Adverse Event             14             15
Lack of Efficacy             8             23
Withdrawal by Subject             5             8
Entry Criteria Not Met             2             2
Physician Decision             1             0
Arm/Group Title Duloxetine 60 mg Placebo Total
Hide Arm/Group Description

Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).

During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.

During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.

Total of all reporting groups
Overall Number of Baseline Participants 191 195 386
Hide Baseline Analysis Population Description
Randomized participants who received at least 1 dose of study drug who had at least 1 post-baseline measurement of primary efficacy [Brief Pain Inventory (BPI) 24-hour average pain severity].
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 195 participants 386 participants
47.8  (12.0) 49.5  (11.7) 48.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 195 participants 386 participants
Female
157
  82.2%
164
  84.1%
321
  83.2%
Male
34
  17.8%
31
  15.9%
65
  16.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 191 participants 195 participants 386 participants
191 195 386
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 191 participants 195 participants 386 participants
191 195 386
1.Primary Outcome
Title Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.90  (0.23) -1.58  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0988
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.70 to 0.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.00  (0.21) -0.60  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.71 to -0.09
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.55  (0.22) -0.94  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.94 to -0.27
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.81  (0.22) -1.09  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.07 to -0.37
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.85  (0.23) -1.41  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.82 to -0.06
Estimation Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)
Hide Description BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.
Time Frame Baseline, up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.60  (0.26) -1.22  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0408
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.74 to -0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Patients Global Impression of Improvement (PGI-I) at Endpoint
Hide Description PGI-I measures the 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 an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.83  (0.16) 3.32  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.76 to -0.22
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) at Endpoint
Hide Description CGI-I measures the clinician's perception of participant 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 an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.83  (0.15) 3.27  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.71 to -0.18
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
Hide Description FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-18.41  (2.57) -13.05  (2.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.35
Confidence Interval (2-Sided) 95%
-9.26 to -1.45
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Hide Description The SF-36 Health Survey is a generic, health-related survey assessing the participant’s quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.
Time Frame Baseline, up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Functioning 7.40  (2.13) 3.06  (2.15)
Role-Physical 8.20  (2.96) 0.44  (2.98)
Bodily Pain 10.95  (2.07) 5.28  (2.08)
General Health 6.55  (1.92) 3.31  (1.94)
Vitality 10.05  (2.51) 3.35  (2.53)
Social Functioning 10.32  (3.04) 3.28  (3.06)
Role-Emotional 5.50  (3.35) -3.63  (3.36)
Mental Health 5.91  (2.51) -2.00  (2.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Physical Functioning
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.34
Confidence Interval (2-Sided) 95%
1.32 to 7.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Role-Physical
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.76
Confidence Interval (2-Sided) 95%
3.57 to 11.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Bodily Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.67
Confidence Interval (2-Sided) 95%
2.76 to 8.59
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments General Health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0192
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
0.53 to 5.96
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Vitality
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.70
Confidence Interval (2-Sided) 95%
3.15 to 10.25
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Social Functioning
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.04
Confidence Interval (2-Sided) 95%
2.74 to 11.34
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Role-Emotional
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.12
Confidence Interval (2-Sided) 95%
4.41 to 13.83
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Mental Health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.91
Confidence Interval (2-Sided) 95%
4.39 to 11.43
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)
Hide Description The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.07  (0.84) -1.22  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.85
Confidence Interval (2-Sided) 95%
-4.32 to -1.38
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
Hide Description WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
WPI -2.34  (0.58) -1.06  (0.60)
SS -1.37  (0.27) -1.00  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments WPI
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-2.12 to -0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Symptom Severity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0906
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.79 to 0.06
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary
Hide Description Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Average Pain -1.82  (0.18) -1.48  (0.18)
Worst Pain -1.81  (0.19) -1.34  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Average Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0755
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.70 to 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Worst Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0232
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.88 to -0.06
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Hide Description BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Time Frame Baseline, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description:
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
Overall Number of Participants Analyzed 191 195
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.91  (0.26) -1.35  (0.26)
Least Pain -1.72  (0.22) -1.23  (0.22)
Pain Right Now -1.77  (0.26) -1.20  (0.26)
Interference With General Activity -2.22  (0.31) -1.76  (0.32)
Interference With Mood -2.17  (0.32) -1.42  (0.33)
Interference With Walking Ability -1.67  (0.29) -1.29  (0.30)
Interference With Normal Work -2.18  (0.31) -1.76  (0.32)
Interference With Relations With Other People -1.09  (0.30) -0.53  (0.30)
Interference With Sleep -1.82  (0.35) -1.57  (0.36)
Interference With Enjoyment of Life -1.90  (0.31) -1.24  (0.32)
Average Interference -1.95  (0.27) -1.44  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Worst Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0126
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.99 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Least Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.87 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Pain Right Now
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0083
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.00 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With General Activity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0807
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.98 to 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Mood
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0057
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.29 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Walking Ability
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1114
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.84 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Normal Work
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1081
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.94 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Relationships With Other People
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0264
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.04 to -0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Sleep
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3959
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.81 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Interference With Enjoyment of Life
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.18 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Duloxetine 60 mg, Placebo
Comments Average Interference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0222
Comments Statistical tests were conducted at a 2-sided alpha level of 0.05.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.96 to -0.07
Estimation Comments [Not Specified]
Time Frame Baseline through 1 week post last dose
Adverse Event Reporting Description Randomized who received at least 1 dose of study drug.
 
Arm/Group Title Duloxetine 60 mg Placebo
Hide Arm/Group Description

Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).

During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.

Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.

During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.

All-Cause Mortality
Duloxetine 60 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine 60 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/194 (0.52%)      1/196 (0.51%)    
Hepatobiliary disorders     
Liver disorder  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine 60 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   147/194 (75.77%)      122/196 (62.24%)    
Blood and lymphatic system disorders     
Anaemia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Cardiac disorders     
Palpitations  1  5/194 (2.58%)  5 1/196 (0.51%)  1
Tachycardia  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Ear and labyrinth disorders     
Tinnitus  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Vertigo  1  4/194 (2.06%)  4 0/196 (0.00%)  0
Eye disorders     
Conjunctival haemorrhage  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Eye irritation  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Vitreous floaters  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  5/194 (2.58%)  6 5/196 (2.55%)  5
Abdominal distension  1  4/194 (2.06%)  4 1/196 (0.51%)  1
Abdominal pain  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Abdominal pain upper  1  6/194 (3.09%)  6 4/196 (2.04%)  4
Constipation  1  29/194 (14.95%)  29 8/196 (4.08%)  8
Dental caries  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Diarrhoea  1  8/194 (4.12%)  8 7/196 (3.57%)  8
Dyschezia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Dyspepsia  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Enterocolitis  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Food poisoning  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Gastritis  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Gastrooesophageal reflux disease  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Glossitis  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Irritable bowel syndrome  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Nausea  1  42/194 (21.65%)  44 9/196 (4.59%)  9
Periodontal disease  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Stomatitis  1  4/194 (2.06%)  5 3/196 (1.53%)  3
Toothache  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Vomiting  1  7/194 (3.61%)  7 4/196 (2.04%)  4
General disorders     
Asthenia  1  4/194 (2.06%)  4 0/196 (0.00%)  0
Chest discomfort  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Chills  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Fatigue  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Feeling abnormal  1  2/194 (1.03%)  3 1/196 (0.51%)  1
Feeling cold  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Malaise  1  9/194 (4.64%)  9 6/196 (3.06%)  6
Oedema  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Pyrexia  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Thirst  1  14/194 (7.22%)  14 7/196 (3.57%)  7
Hepatobiliary disorders     
Hepatic function abnormal  1  5/194 (2.58%)  5 4/196 (2.04%)  4
Infections and infestations     
Bronchitis  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Cystitis  1  3/194 (1.55%)  4 3/196 (1.53%)  3
Ear infection  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Folliculitis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Gastroenteritis  1  2/194 (1.03%)  2 2/196 (1.02%)  2
Gastroenteritis viral  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Gingivitis  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Hand-foot-and-mouth disease  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Herpes simplex  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Herpes zoster  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Hordeolum  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Impetigo  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Influenza  1  3/194 (1.55%)  3 0/196 (0.00%)  0
Keratitis bacterial  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Nasopharyngitis  1  26/194 (13.40%)  39 29/196 (14.80%)  37
Otitis media  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Paronychia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Periodontitis  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Pertussis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Pharyngitis  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Pneumonia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Tinea pedis  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Upper respiratory tract infection  1  2/194 (1.03%)  4 0/196 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  3/194 (1.55%)  3 2/196 (1.02%)  2
Excoriation  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Hand fracture  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Heat illness  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Ligament sprain  1  3/194 (1.55%)  3 3/196 (1.53%)  3
Thermal burn  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Wound  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Investigations     
Alanine aminotransferase increased  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Blood alkaline phosphatase increased  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Blood bilirubin increased  1  5/194 (2.58%)  6 4/196 (2.04%)  4
Blood cholesterol increased  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Blood creatine phosphokinase increased  1  3/194 (1.55%)  3 3/196 (1.53%)  3
Blood potassium increased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Blood triglycerides increased  1  2/194 (1.03%)  2 2/196 (1.02%)  2
Blood uric acid increased  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Blood urine present  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Eosinophil count increased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Gamma-glutamyltransferase increased  1  4/194 (2.06%)  4 4/196 (2.04%)  4
Haematocrit decreased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Haematocrit increased  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Haemoglobin decreased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Haemoglobin increased  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Heart rate increased  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Lymphocyte count decreased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Protein total decreased  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Protein urine present  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Red blood cell count decreased  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Red blood cell count increased  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Weight decreased  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Weight increased  1  1/194 (0.52%)  1 2/196 (1.02%)  2
White blood cell count decreased  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  13/194 (6.70%)  13 1/196 (0.51%)  1
Dyslipidaemia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Hypouricaemia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Arthritis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Back pain  1  2/194 (1.03%)  2 4/196 (2.04%)  4
Intervertebral disc protrusion  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Musculoskeletal stiffness  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Myalgia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Neck mass  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Nodal osteoarthritis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Periarthritis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Plantar fasciitis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Synovial cyst  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Tenosynovitis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Trigger finger  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Nervous system disorders     
Autonomic nervous system imbalance  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Depressed level of consciousness  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Dizziness  1  11/194 (5.67%)  11 2/196 (1.02%)  2
Dizziness postural  1  2/194 (1.03%)  2 1/196 (0.51%)  1
Dysgeusia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Dyskinesia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Head discomfort  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Headache  1  9/194 (4.64%)  11 6/196 (3.06%)  6
Hypoaesthesia  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Migraine  1  1/194 (0.52%)  1 2/196 (1.02%)  2
Sensory disturbance  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Sleep paralysis  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Somnolence  1  51/194 (26.29%)  52 21/196 (10.71%)  21
Syncope  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Tremor  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Depression  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Insomnia  1  2/194 (1.03%)  2 5/196 (2.55%)  5
Limited symptom panic attack  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Middle insomnia  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Nightmare  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Panic attack  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Renal and urinary disorders     
Dysuria  1  3/194 (1.55%)  3 0/196 (0.00%)  0
Hypertonic bladder  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Oliguria  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Pollakiuria  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Reproductive system and breast disorders     
Erectile dysfunction  1  0/35 (0.00%)  0 1/31 (3.23%)  1
Menopausal symptoms  1  1/159 (0.63%)  1 0/165 (0.00%)  0
Metrorrhagia  1  1/159 (0.63%)  1 0/165 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Cough  1  1/194 (0.52%)  1 1/196 (0.51%)  1
Epistaxis  1  1/194 (0.52%)  2 0/196 (0.00%)  0
Hyperventilation  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Oropharyngeal discomfort  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Oropharyngeal pain  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Rhinitis allergic  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Upper respiratory tract inflammation  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Yawning  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Dermatitis  1  1/194 (0.52%)  1 2/196 (1.02%)  2
Dermatitis atopic  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Dermatitis contact  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Drug eruption  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Eczema  1  1/194 (0.52%)  1 8/196 (4.08%)  8
Erythema  1  0/194 (0.00%)  0 2/196 (1.02%)  2
Hyperhidrosis  1  2/194 (1.03%)  2 0/196 (0.00%)  0
Miliaria  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Prurigo  1  0/194 (0.00%)  0 1/196 (0.51%)  1
Pruritus  1  5/194 (2.58%)  5 2/196 (1.02%)  2
Purpura  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Rash  1  4/194 (2.06%)  5 2/196 (1.02%)  2
Rash papular  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Urticaria  1  0/194 (0.00%)  0 4/196 (2.04%)  4
Vascular disorders     
Hot flush  1  1/194 (0.52%)  1 0/196 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: NCT01552057     History of Changes
Other Study ID Numbers: 14377
F1J-JE-HMGZ ( Other Identifier: Eli Lilly and Company )
First Submitted: March 9, 2012
First Posted: March 13, 2012
Results First Submitted: December 12, 2014
Results First Posted: December 19, 2014
Last Update Posted: January 16, 2015