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A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing

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ClinicalTrials.gov Identifier: NCT01808612
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Fluoxetine
Drug: Placebo
Enrollment 513
Recruitment Details  
Pre-assignment Details This study consisted of 3 periods: a single-blind screening period (1 week of placebo), a double-blind short-term treatment period (1 week of placebo followed by randomization in a 2:1:3 fashion to 20 milligrams [mg] fluoxetine, 40 mg fluoxetine, or placebo, respectively, for 6 weeks), and a single-blind discontinuation period (2 weeks of placebo).
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description

Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks

Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks

Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks

Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks

Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks

Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks

Period Title: Treatment Period
Started 169 84 260
Received at Least 1 Dose of Study Drug 168 [1] 83 [1] 259 [1]
Completed 154 [2] 77 [3] 246 [4]
Not Completed 15 7 14
Reason Not Completed
Adverse Event             8             4             3
Lost to Follow-up             2             2             1
Protocol Violation             1             0             0
Withdrawal by Subject             1             0             4
Physician Decision             1             0             4
Sponsor Decision             1             0             0
Lack of Efficacy             1             1             2
[1]
Only these participants were included in the study analyses (ie, Full Analysis Set).
[2]
67 participants who completed the Treatment Period did not enter the Discontinuation Period.
[3]
39 participants who completed the Treatment Period did not enter the Discontinuation Period.
[4]
101 participants who completed the Treatment Period did not enter the Discontinuation Period.
Period Title: Discontinuation Period
Started 87 38 145
Completed 85 37 145
Not Completed 2 1 0
Reason Not Completed
Adverse Event             1             0             0
Physician Decision             1             0             0
Lost to Follow-up             0             1             0
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo Total
Hide Arm/Group Description 20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks Placebo (capsules) administered orally, once daily, for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 168 83 259 510
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 83 participants 259 participants 510 participants
40.05  (11.19) 39.58  (10.56) 38.54  (11.65) 39.20  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 83 participants 259 participants 510 participants
Female
83
  49.4%
33
  39.8%
129
  49.8%
245
  48.0%
Male
85
  50.6%
50
  60.2%
130
  50.2%
265
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 83 participants 259 participants 510 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
168
 100.0%
83
 100.0%
259
 100.0%
510
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 83 participants 259 participants 510 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
168
 100.0%
83
 100.0%
259
 100.0%
510
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 168 participants 83 participants 259 participants 510 participants
168 83 259 510
1.Primary Outcome
Title Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score
Hide Description HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 259
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.18  (0.57) -6.25  (0.77) -6.91  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Fluoxetine, Placebo
Comments Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
-0.55 to 2.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores
Hide Description HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 259
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
HAMD17 total score -5.59  (0.53) -5.61  (0.71) -6.27  (0.45)
Maier subscale score -3.35  (0.30) -3.39  (0.40) -3.30  (0.26)
Anxiety/Somatization subscale score -2.04  (0.21) -1.84  (0.28) -2.06  (0.18)
Retardation/Somatization subscale score -2.00  (0.20) -2.21  (0.27) -2.23  (0.17)
Sleep subscale score -0.83  (0.15) -0.81  (0.20) -1.10  (0.13)
3.Secondary Outcome
Title Percentage of Participants Achieving a Response at 6-Week Endpoint
Hide Description The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.
Time Frame up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 259
Measure Type: Number
Unit of Measure: percentage of participants
23.8 18.1 27.8
4.Secondary Outcome
Title Percentage of Participants Achieving a Remission at 6-Week Endpoint
Hide Description The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.
Time Frame up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 258
Measure Type: Number
Unit of Measure: percentage of participants
9.5 9.6 15.1
5.Secondary Outcome
Title Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
Hide Description CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 259
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.69  (0.08) -0.67  (0.11) -0.81  (0.07)
6.Secondary Outcome
Title Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Hide Description SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.
Time Frame Baseline, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 167 81 259
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total score (n=167, 81, 259) -1.76  (0.59) -1.55  (0.78) -1.99  (0.53)
Work/School subscale score (n=143, 64, 226) -0.79  (0.27) -0.34  (0.36) -0.88  (0.24)
Social/Leisure subscale score (n=167, 81, 259) -0.66  (0.23) -0.81  (0.30) -0.70  (0.21)
Family/Home subscale score (n=167, 81, 259) -0.47  (0.21) -0.30  (0.28) -0.41  (0.19)
7.Secondary Outcome
Title Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Time Frame Baseline through 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.
Arm/Group Title 20 mg Fluoxetine 40 mg Fluoxetine Placebo
Hide Arm/Group Description:
20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
Placebo (capsules) administered orally, once daily, for 6 weeks
Overall Number of Participants Analyzed 168 83 259
Measure Type: Number
Unit of Measure: participants
Suicidal behavior 0 0 1
Suicidal ideation 5 6 8
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were reported for all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo (Treatment Period) 20 mg Fluoxetine (Treatment Period) 40 mg Fluoxetine (Treatment Period) Placebo (Discontinuation From Placebo) Placebo (Discontinuation From 20 mg Fluoxetine) Placebo (Discontinuation From 40 mg Fluoxetine)
Hide Arm/Group Description Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
All-Cause Mortality
Placebo (Treatment Period) 20 mg Fluoxetine (Treatment Period) 40 mg Fluoxetine (Treatment Period) Placebo (Discontinuation From Placebo) Placebo (Discontinuation From 20 mg Fluoxetine) Placebo (Discontinuation From 40 mg Fluoxetine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Treatment Period) 20 mg Fluoxetine (Treatment Period) 40 mg Fluoxetine (Treatment Period) Placebo (Discontinuation From Placebo) Placebo (Discontinuation From 20 mg Fluoxetine) Placebo (Discontinuation From 40 mg Fluoxetine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/259 (0.77%)      0/168 (0.00%)      0/83 (0.00%)      1/145 (0.69%)      0/87 (0.00%)      0/38 (0.00%)    
Gastrointestinal disorders             
Colitis ulcerative  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 1/145 (0.69%)  1 0/87 (0.00%)  0 0/38 (0.00%)  0
Psychiatric disorders             
Suicide attempt  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Reproductive system and breast disorders             
Infertility male  1  1/130 (0.77%)  1 0/85 (0.00%)  0 0/50 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (Treatment Period) 20 mg Fluoxetine (Treatment Period) 40 mg Fluoxetine (Treatment Period) Placebo (Discontinuation From Placebo) Placebo (Discontinuation From 20 mg Fluoxetine) Placebo (Discontinuation From 40 mg Fluoxetine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/259 (28.96%)      49/168 (29.17%)      30/83 (36.14%)      5/145 (3.45%)      5/87 (5.75%)      2/38 (5.26%)    
Blood and lymphatic system disorders             
Anaemia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Cardiac disorders             
Atrioventricular block first degree  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Palpitations  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Tachycardia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Ear and labyrinth disorders             
Sudden hearing loss  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Tinnitus  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Vertigo  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Endocrine disorders             
Hyperthyroidism  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Thyroiditis  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Eye disorders             
Vision blurred  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastrointestinal disorders             
Abdominal distension  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Abdominal pain  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Abdominal pain upper  1  2/259 (0.77%)  2 1/168 (0.60%)  2 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Constipation  1  5/259 (1.93%)  5 1/168 (0.60%)  1 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Dental caries  1  3/259 (1.16%)  3 2/168 (1.19%)  2 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Diarrhoea  1  3/259 (1.16%)  3 2/168 (1.19%)  2 1/83 (1.20%)  1 0/145 (0.00%)  0 1/87 (1.15%)  1 0/38 (0.00%)  0
Dyspepsia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Enteritis  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastritis  1  1/259 (0.39%)  1 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastritis atrophic  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastrointestinal disorder  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gingival inflammation  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Irritable bowel syndrome  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Nausea  1  0/259 (0.00%)  0 5/168 (2.98%)  5 4/83 (4.82%)  4 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Stomatitis  1  3/259 (1.16%)  4 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Vomiting  1  2/259 (0.77%)  2 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 1/38 (2.63%)  1
General disorders             
Malaise  1  0/259 (0.00%)  0 2/168 (1.19%)  2 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Oedema peripheral  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Swelling  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Thirst  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hepatobiliary disorders             
Alcoholic liver disease  1  0/259 (0.00%)  0 1/168 (0.60%)  1 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hepatic function abnormal  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Infections and infestations             
Enterocolitis bacterial  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastroenteritis  1  1/259 (0.39%)  1 1/168 (0.60%)  1 3/83 (3.61%)  3 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gastroenteritis viral  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 1/38 (2.63%)  1
Gingivitis  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 1/87 (1.15%)  1 0/38 (0.00%)  0
Influenza  1  2/259 (0.77%)  2 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Nasopharyngitis  1  17/259 (6.56%)  17 6/168 (3.57%)  7 4/83 (4.82%)  5 3/145 (2.07%)  3 0/87 (0.00%)  0 0/38 (0.00%)  0
Oral herpes  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Pharyngitis  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Sinusitis  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Injury, poisoning and procedural complications             
Accidental overdose  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Contusion  1  1/259 (0.39%)  1 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hand fracture  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Heat illness  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Thermal burn  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  3/259 (1.16%)  3 2/168 (1.19%)  2 0/83 (0.00%)  0 0/145 (0.00%)  0 1/87 (1.15%)  1 0/38 (0.00%)  0
Aspartate aminotransferase increased  1  1/259 (0.39%)  1 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Blood bilirubin increased  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 1/145 (0.69%)  1 0/87 (0.00%)  0 0/38 (0.00%)  0
Blood creatine phosphokinase increased  1  2/259 (0.77%)  2 6/168 (3.57%)  6 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Blood thyroid stimulating hormone decreased  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Blood triglycerides increased  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Blood urine present  1  2/259 (0.77%)  2 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Electrocardiogram qt prolonged  1  1/259 (0.39%)  1 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Electrocardiogram st segment depression  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Endoscopy large bowel  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/259 (0.39%)  1 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hepatic enzyme increased  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Liver function test abnormal  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Neutrophil count decreased  1  2/259 (0.77%)  2 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Protein urine  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Qrs axis abnormal  1  0/259 (0.00%)  0 2/168 (1.19%)  2 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Urine ketone body present  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Weight decreased  1  1/259 (0.39%)  1 3/168 (1.79%)  3 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
White blood cell count decreased  1  3/259 (1.16%)  3 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  0/259 (0.00%)  0 2/168 (1.19%)  2 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hypercreatininaemia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthritis  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Back pain  1  3/259 (1.16%)  3 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Intervertebral disc protrusion  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Joint swelling  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Myalgia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Duodenal neoplasm  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Nervous system disorders             
Amnesia  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Anterograde amnesia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Cervicobrachial syndrome  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Dizziness  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Dysgeusia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Headache  1  2/259 (0.77%)  2 2/168 (1.19%)  3 0/83 (0.00%)  0 0/145 (0.00%)  0 2/87 (2.30%)  2 0/38 (0.00%)  0
Somnolence  1  2/259 (0.77%)  2 6/168 (3.57%)  6 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Tremor  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Psychiatric disorders             
Depression  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Impatience  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Insomnia  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Irritability  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Major depression  1  0/259 (0.00%)  0 3/168 (1.79%)  3 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Restlessness  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Suicidal ideation  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 1/145 (0.69%)  1 0/87 (0.00%)  0 0/38 (0.00%)  0
Renal and urinary disorders             
Pollakiuria  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Proteinuria  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Reproductive system and breast disorders             
Dysmenorrhoea  1  1/129 (0.78%)  1 1/83 (1.20%)  2 0/33 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Ejaculation delayed  1  0/130 (0.00%)  0 0/85 (0.00%)  0 1/50 (2.00%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Productive cough  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Upper respiratory tract inflammation  1  0/259 (0.00%)  0 1/168 (0.60%)  1 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Skin and subcutaneous tissue disorders             
Dermatitis allergic  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Dry skin  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Dyshidrotic eczema  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Eczema  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Hyperhidrosis  1  0/259 (0.00%)  0 1/168 (0.60%)  1 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Miliaria  1  1/259 (0.39%)  1 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Pruritus  1  1/259 (0.39%)  1 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Rash  1  0/259 (0.00%)  0 0/168 (0.00%)  0 0/83 (0.00%)  0 0/145 (0.00%)  0 1/87 (1.15%)  1 0/38 (0.00%)  0
Urticaria  1  1/259 (0.39%)  1 3/168 (1.79%)  3 2/83 (2.41%)  2 1/145 (0.69%)  1 0/87 (0.00%)  0 0/38 (0.00%)  0
Vascular disorders             
Orthostatic hypotension  1  0/259 (0.00%)  0 0/168 (0.00%)  0 1/83 (1.20%)  1 0/145 (0.00%)  0 0/87 (0.00%)  0 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01808612     History of Changes
Other Study ID Numbers: 14595
B1Y-JE-HCLV ( Other Identifier: Eli Lilly and Company )
First Submitted: March 7, 2013
First Posted: March 11, 2013
Results First Submitted: April 24, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015