Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

Phase 3

Terminated

• Conditions: Sleep Disorders, Intrinsic; Sleep Initiation and Maintenance Disorders; Dyssomnias; Sleep Disorders; Mental Disorders
• Interventions: Drug: esmirtazapine

• Registration Number: NCT00750919
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-11
• Study Start: 2008-10-07
• Primary Completion: 2010-03-10
• Study Completion: 2010-03-10
• Results First Submitted: 2014-05-22
• Results First Submitted QC: 2014-05-22
• Results First Posted: 2014-06-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Sign written informed consent
• Completed clinical trial 21106/P05701/MK-8265-002

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Exclusion Criteria

• Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
• Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esmirtazapine	esmirtazapine	Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants Discontinuing Due to AEs	Up to 26 weeks	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Change From Baseline in Total Sleep Time (TST)	Baseline and Week 26	TST was defined as the time recorded for sleep diary question 6 "how much time did you actually spend sleeping" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Number of Participants Experiencing Adverse Events (AEs)	Up to 30 weeks	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Wake Time After Sleep Onset (WASO)	Baseline and Week 26	WASO was defined as the time recorded for sleep diary question 5 "how much time were you awake, after falling asleep initially" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Change From Baseline in Sleep Latency (SL)	Baseline and Week 26	SL was defined as the time recorded for sleep diary question 3 "how long did it take you to fall asleep', " as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.