Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00266357
First received: December 14, 2005
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.


Condition Intervention Phase
Primary Insomnia
Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
Drug: Placebo / Duration of Treatment: 2 days for screening period
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

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

Primary Outcome Measures:
  • Mean of total sleep time over 2 nights.

Secondary Outcome Measures:
  • Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.

Estimated Enrollment: 50
Study Start Date: November 2005
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of primary insomnia

Exclusion Criteria:

  • Patients with an active psychiatric disorder other than primary insomnia
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266357

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00266357     History of Changes
Other Study ID Numbers: 2005_107
Study First Received: December 14, 2005
Last Updated: May 23, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 20, 2014