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

This study has been terminated.
(This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00750919
First received: September 10, 2008
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Drug: esmirtazapine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Total Sleep Time (TST) [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Discontinuing Due to AEs [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Change From Baseline in Sleep Latency (SL) [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
    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.


Enrollment: 184
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esmirtazapine
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.
Drug: esmirtazapine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00750919     History of Changes
Other Study ID Numbers: P05721, 176003, 2007-005237-10
Study First Received: September 10, 2008
Results First Received: May 22, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Mental Disorders
Psychotic Disorders
Disease
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Dyssomnias

ClinicalTrials.gov processed this record on September 22, 2014