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A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

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ClinicalTrials.gov Identifier: NCT00506389
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : August 6, 2014
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: Esmirtazapine
Drug: Placebo
Enrollment 419
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Esmirtazapine 3.0 mg Esmirtazapine 4.5 mg Placebo
Hide Arm/Group Description Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Period Title: In-treatment Period
Started 143 139 137
All Participants Treated 139 138 136
Completed 117 124 125
Not Completed 26 15 12
Reason Not Completed
Not specified             3             3             4
Lost to Follow-up             0             0             1
Lack of compliance             1             0             0
Reasons not related to trial             4             1             0
Withdrawal by Subject             3             3             4
Lack of Efficacy             0             2             0
Adverse Event             11             5             2
Randomized but not treated             4             1             1
Period Title: Follow-up Period
Started 139 [1] 138 [2] 136 [3]
Completed 139 138 136
Not Completed 0 0 0
[1]
22 participants who discontinued treatment entered the Follow-up Period.
[2]
14 participants who discontinued treatment entered the Follow-up Period.
[3]
11 participants who discontinued treatment entered the Follow-up Period.
Arm/Group Title Esmirtazapine 3.0 mg Esmirtazapine 4.5 mg Placebo Total
Hide Arm/Group Description Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period. Total of all reporting groups
Overall Number of Baseline Participants 143 139 137 419
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants 139 participants 137 participants 419 participants
43.5  (11.3) 44.5  (11.5) 46.6  (10.5) 44.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 139 participants 137 participants 419 participants
Female
98
  68.5%
89
  64.0%
90
  65.7%
277
  66.1%
Male
45
  31.5%
50
  36.0%
47
  34.3%
142
  33.9%
1.Primary Outcome
Title Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
Hide Description WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.
Time Frame From Day 1 to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.
Arm/Group Title Esmirtazapine 3.0 mg Esmirtazapine 4.5 mg Placebo
Hide Arm/Group Description:
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Overall Number of Participants Analyzed 133 133 132
Mean (Standard Deviation)
Unit of Measure: Minutes
45.6  (25.7) 45.5  (26.5) 76.1  (46.0)
2.Secondary Outcome
Title Average Latency to Persistent Sleep (LPS) During the In-Treatment Period
Hide Description LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
Time Frame From Day 1 to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.
Arm/Group Title Esmirtazapine 3.0 mg Esmirtazapine 4.5 mg Placebo
Hide Arm/Group Description:
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Overall Number of Participants Analyzed 133 133 132
Mean (Standard Deviation)
Unit of Measure: Minutes
28.7  (28.4) 26.1  (23.0) 40.5  (27.3)
3.Secondary Outcome
Title Average Subjective Total Sleep Time (TST) During the In-Treatment Period
Hide Description TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.
Time Frame From Day 1 to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.
Arm/Group Title Esmirtazapine 3.0 mg Esmirtazapine 4.5 mg Placebo
Hide Arm/Group Description:
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
Overall Number of Participants Analyzed 133 133 132
Mean (Standard Deviation)
Unit of Measure: Minutes
384.6  (63.6) 384.6  (66.2) 351.6  (57.2)
Time Frame Day 1 to Day 50
Adverse Event Reporting Description Adverse events (AEs) were monitored for All Participants Treated (receiving at least one dose of study drug) during the 6-week In-treatment Period and the subsequent 1-week Follow-up Period. Six participants did not receive study drug and were not included.
 
Arm/Group Title Esmirtazapine 3.0 mg In-treatment Esmirtazapine 4.5 mg In-treatment Placebo In-treatment Esmirtazapine 3.0 mg Follow-up Esmirtazapine 4.5 mg Follow-up Placebo Follow-up
Hide Arm/Group Description Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening. After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period. After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period. After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
All-Cause Mortality
Esmirtazapine 3.0 mg In-treatment Esmirtazapine 4.5 mg In-treatment Placebo In-treatment Esmirtazapine 3.0 mg Follow-up Esmirtazapine 4.5 mg Follow-up Placebo Follow-up
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
Esmirtazapine 3.0 mg In-treatment Esmirtazapine 4.5 mg In-treatment Placebo In-treatment Esmirtazapine 3.0 mg Follow-up Esmirtazapine 4.5 mg Follow-up Placebo Follow-up
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   0/139 (0.00%)      1/138 (0.72%)      0/136 (0.00%)      0/139 (0.00%)      0/138 (0.00%)      0/136 (0.00%)    
Blood and lymphatic system disorders             
Neutropenia  1  0/139 (0.00%)  0 1/138 (0.72%)  1 0/136 (0.00%)  0 0/139 (0.00%)  0 0/138 (0.00%)  0 0/136 (0.00%)  0
Infections and infestations             
Pneumonia streptococcal  1  0/139 (0.00%)  0 1/138 (0.72%)  1 0/136 (0.00%)  0 0/139 (0.00%)  0 0/138 (0.00%)  0 0/136 (0.00%)  0
Sepsis  1  0/139 (0.00%)  0 1/138 (0.72%)  1 0/136 (0.00%)  0 0/139 (0.00%)  0 0/138 (0.00%)  0 0/136 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Esmirtazapine 3.0 mg In-treatment Esmirtazapine 4.5 mg In-treatment Placebo In-treatment Esmirtazapine 3.0 mg Follow-up Esmirtazapine 4.5 mg Follow-up Placebo Follow-up
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   20/139 (14.39%)      24/138 (17.39%)      13/136 (9.56%)      2/139 (1.44%)      1/138 (0.72%)      1/136 (0.74%)    
Nervous system disorders             
Headache  1  5/139 (3.60%)  7 7/138 (5.07%)  9 9/136 (6.62%)  11 2/139 (1.44%)  2 1/138 (0.72%)  1 1/136 (0.74%)  1
Somnolence  1  16/139 (11.51%)  18 18/138 (13.04%)  20 4/136 (2.94%)  4 0/139 (0.00%)  0 0/138 (0.00%)  0 0/136 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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.
All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the Sponsor, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development Group Leader
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00506389     History of Changes
Other Study ID Numbers: P05707
176002 ( Other Identifier: Organon )
First Submitted: July 23, 2007
First Posted: July 25, 2007
Results First Submitted: July 14, 2014
Results First Posted: August 6, 2014
Last Update Posted: October 2, 2018