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Duloxetine for the Treatment of Generalized Anxiety Disorder

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: NCT00803361
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 17, 2010
Last Update Posted : December 17, 2010
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Generalized Anxiety Disorder
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 60 to 120 mg, capsules, oral, once a day for 15 weeks placebo capsules, oral, once a day for 15 weeks
Period Title: Overall Study
Started 108 102
Completed 82 74
Not Completed 26 28
Reason Not Completed
Adverse Event             13             3
Lack of Efficacy             4             13
Lost to Follow-up             1             2
Physician Decision             1             0
Protocol Violation             2             4
Withdrawal by Subject             5             6
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description 60 to 120 mg, capsules, oral, once a day for 15 weeks placebo capsules, oral, once a day for 15 weeks Total of all reporting groups
Overall Number of Baseline Participants 108 102 210
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 102 participants 210 participants
37.26  (11.85) 38.02  (12.03) 37.63  (11.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 102 participants 210 participants
Female
50
  46.3%
56
  54.9%
106
  50.5%
Male
58
  53.7%
46
  45.1%
104
  49.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 102 participants 210 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
108
 100.0%
102
 100.0%
210
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 108 participants 102 participants 210 participants
108 102 210
1.Primary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Hide Description A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 12.76  (2.89) 13.56  (2.96)
Change from Baseline -6.38  (4.44) -5.29  (4.78)
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 0.006
Comments p-value is for Change from Baseline.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-2.76 to -0.48
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
Hide Description The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 24.50  (5.81) 24.24  (5.16)
Change from Baseline -14.42  (9.05) -11.62  (8.31)
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 0.024
Comments p-value is for Change from Baseline
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.56
Confidence Interval (2-Sided) 95%
-4.78 to -0.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
Hide Description Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
2.08  (0.97) 2.54  (1.20)
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 0.004
Comments [Not Specified]
Method ANOVA
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]
4.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Hide Description BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. 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.
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Severity of Worst Pain Baseline 3.39  (2.84) 4.22  (3.03)
Severity of Worst Pain Change -1.78  (2.44) -1.88  (2.78)
Severity of Least Pain Baseline 1.17  (1.51) 1.51  (1.81)
Severity of Least Pain Change -0.67  (1.32) -0.45  (1.70)
Severity of Average Pain Baseline 2.36  (2.26) 2.77  (2.20)
Severity of Average Pain Change -1.25  (1.94) -0.97  (2.06)
Severity of Pain Right Now Baseline 2.21  (2.58) 2.30  (2.68)
Severity of Pain Right Now Change -1.41  (2.29) -0.77  (2.54)
Interference of Pain, General Activity, Baseline 2.60  (2.81) 2.66  (2.69)
Interference of Pain, General Activity, Change -1.43  (2.40) -1.06  (2.43)
Interference of Pain, Mood, Baseline 2.97  (3.04) 3.40  (2.87)
Interference of Pain, Mood, Change -1.49  (2.71) -1.44  (2.57)
Interference of Pain,Walking Ability, Baseline 1.31  (2.07) 1.56  (2.16)
Interference of Pain,Walking Ability, Change -0.63  (2.01) -0.47  (1.95)
Int. of Pain, Normal Work, Baseline 2.53  (2.77) 2.44  (2.67)
Int. of Pain, Normal Work, Change -1.25  (2.54) -0.96  (2.43)
Int. of Pain, Relations with Others, Baseline 2.01  (2.59) 2.01  (2.52)
Int. of Pain, Relations with Others, Change -1.07  (2.22) -0.88  (2.07)
Interference of Pain, Sleep, Baseline 2.55  (3.09) 3.23  (3.15)
Interference of Pain, Sleep, Change -1.16  (2.56) -1.45  (2.68)
Interference of Pain, Enjoyment of Life, Baseline 2.51  (2.80) 2.62  (2.37)
Interference of Pain, Enjoyment of Life, Change -1.27  (2.73) -0.99  (2.20)
Mean Interference Score, Baseline 2.36  (2.46) 2.56  (2.25)
Mean Interference Score, Change -1.18  (2.13) -1.04  (1.84)
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 0.125
Comments p-value is for Severity of Worst Pain Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.93 to 0.11
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 0.014
Comments p-value is for Severity of Least Pain Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.75 to -0.09
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 0.012
Comments p-value is for Severity of Average Pain Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.93 to -0.11
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 0.002
Comments p-value is for Severity of Pain Right Now Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.14 to -0.25
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 0.101
Comments p-value is for Interference of Pain, General Activity, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.87 to 0.08
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 0.252
Comments p-value is for Interference of Pain, Mood, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.83 to 0.22
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 0.149
Comments p-value is for Interference of Pain,Walking Ability, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.72 to 0.11
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 0.367
Comments p-value is for Interference of Pain, Normal Work, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.71 to 0.26
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 0.395
Comments p-value is for Interference of Pain, Relations with Others, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.59 to 0.24
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 0.731
Comments p-value is for Interference of Pain, Sleep, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.63 to 0.44
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 0.186
Comments p-value is for Interference of Pain, Enjoyment of Life, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.85 to 0.17
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 0.220
Comments p-value is for Mean Interference Score, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.67 to 0.16
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Hide Description The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Symptoms Disrupted Work- Baseline (N=101,N=94) 5.94  (2.01) 5.85  (1.72)
Symptoms Disrupted Work- Change(N=101,N=94) -3.27  (3.06) -2.59  (2.69)
Symptoms Disrupted Social/Leisure - Baseline 5.84  (1.89) 5.73  (1.94)
Symptoms Disrupted Social/Leisure - Change -3.21  (2.90) -2.60  (2.68)
Symptoms Disrupted Family Life - Baseline 5.50  (1.78) 5.39  (1.83)
Symptoms Disrupted Family Life - Change -3.07  (2.55) -2.45  (2.43)
Global Functional Impairment Total Score -Baseline 17.24  (4.58) 17.05  (4.52)
Global Functional Impairment Total Score -Change -9.51  (7.56) -7.71  (7.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments p-value is for symptoms have disrupted your work/schoolwork - change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.29 to 0.06
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 0.140
Comments p-value is for symptoms disrupted social/leisure - change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-1.16 to 0.17
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 0.087
Comments p-value is for symptoms disrupted family life - change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.14 to 0.08
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 0.083
Comments p-value is for Global Functional Impairment Total Score - change
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-3.46 to 0.21
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Hide Description VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 95 88
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Severity of Overall Pain, Past Week, Baseline 27.56  (26.05) 31.94  (27.62)
Severity of Overall Pain, Past Week, Change -15.28  (26.30) -13.40  (29.42)
Severity of Headaches, Past Week, Baseline 21.11  (26.33) 24.52  (26.68)
Severity of Headaches, Past Week, Change -9.44  (24.61) -10.57  (26.36)
Severity of Back Pain, Past Week, Baseline 18.13  (24.99) 17.40  (25.41)
Severity of Back Pain, Past Week, Change -9.40  (21.19) -3.36  (26.55)
Severity of Shoulder Pain, Past Week, Baseline 16.53  (23.96) 19.68  (27.74)
Severity of Shoulder Pain, Past Week, Change -8.85  (23.55) -8.52  (27.12)
Pain Interference, Daily Activities, Baseline 27.19  (29.26) 26.41  (26.03)
Pain Interference, Daily Activities, Change -16.92  (25.41) -12.69  (27.53)
Pain During Waking Hours, Past Week, Baseline 26.84  (-28.48) 33.22  (33.44)
Pain During Waking Hours, Past Week, Change -16.77  (27.53) -14.58  (29.74)
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 0.063
Comments p-value is for Severity of Overall Pain, Past Week, Change
Method ANCOVA
Comments Model: Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.32
Confidence Interval (2-Sided) 95%
-10.93 to 0.30
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 0.660
Comments p-value is for Severity of Headaches, Past Week, Change.
Method ANCOVA
Comments Model: Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-6.64 to 4.22
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 0.025
Comments p-value is for Severity of Back Pain, Past Week, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.03
Confidence Interval (2-Sided) 95%
-11.30 to -0.76
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 0.260
Comments p-value is for Severity of Shoulder Pain, Past Week, Change.
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.93
Confidence Interval (2-Sided) 95%
-8.06 to 2.19
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 0.145
Comments p-value is for Pain Interference, Daily Activities, Change
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.67
Confidence Interval (2-Sided) 95%
-8.61 to 1.28
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 0.011
Comments p-value is for Pain During Waking Hours, Past Week, Change
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.15
Confidence Interval (2-Sided) 95%
-12.64 to -1.66
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
Hide Description A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time Frame Baseline, Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline result within each treatment group.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
60 to 120 mg, capsules, oral, once a day for 15 weeks
placebo capsules, oral, once a day for 15 weeks
Overall Number of Participants Analyzed 107 100
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline 6.90  (3.49) 6.62  (3.35)
Change from Baseline -2.95  (3.82) -1.96  (3.60)
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 0.068
Comments p-value is for Change from Baseline
Method ANCOVA
Comments Change = Treatment + Pooled Investigator + Baseline
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.72 to 0.06
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 60 to 120 mg, capsules, oral, once a day for 15 weeks placebo capsules, oral, once a day for 15 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   0/108 (0.00%)      1/102 (0.98%)    
Psychiatric disorders     
Suicide attempt  1  0/108 (0.00%)  0 1/102 (0.98%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/108 (62.04%)      45/102 (44.12%)    
Cardiac disorders     
Palpitations  1  3/108 (2.78%)  3 2/102 (1.96%)  2
Eye disorders     
Vision blurred  1  3/108 (2.78%)  3 1/102 (0.98%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  7/108 (6.48%)  7 1/102 (0.98%)  1
Constipation  1  10/108 (9.26%)  11 4/102 (3.92%)  4
Diarrhoea  1  1/108 (0.93%)  1 4/102 (3.92%)  5
Dry mouth  1  10/108 (9.26%)  11 4/102 (3.92%)  4
Nausea  1  30/108 (27.78%)  32 9/102 (8.82%)  9
Vomiting  1  6/108 (5.56%)  6 1/102 (0.98%)  1
General disorders     
Asthenia  1  5/108 (4.63%)  6 1/102 (0.98%)  1
Fatigue  1  4/108 (3.70%)  4 1/102 (0.98%)  1
Infections and infestations     
Upper respiratory tract infection  1  0/108 (0.00%)  0 3/102 (2.94%)  3
Metabolism and nutrition disorders     
Anorexia  1  6/108 (5.56%)  6 2/102 (1.96%)  2
Decreased appetite  1  3/108 (2.78%)  3 2/102 (1.96%)  2
Nervous system disorders     
Dizziness  1  15/108 (13.89%)  16 4/102 (3.92%)  4
Headache  1  3/108 (2.78%)  3 4/102 (3.92%)  4
Somnolence  1  12/108 (11.11%)  14 1/102 (0.98%)  2
Tremor  1  4/108 (3.70%)  4 0/102 (0.00%)  0
Psychiatric disorders     
Insomnia  1  0/108 (0.00%)  0 5/102 (4.90%)  5
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  7/108 (6.48%)  7 2/102 (1.96%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00803361     History of Changes
Other Study ID Numbers: 11517
F1J-MC-HMFJ ( Other Identifier: Eli Lilly and Company )
First Submitted: December 3, 2008
First Posted: December 5, 2008
Results First Submitted: November 19, 2010
Results First Posted: December 17, 2010
Last Update Posted: December 17, 2010