MK0928 Study in Adult Patients With Primary Insomnia

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00266344
First received: December 14, 2005
Last updated: October 28, 2009
Last verified: October 2009
  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 3 Weeks
Drug: Placebo / Duration of Treatment 3 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0928 Phase IIb Dose-range Finding Study -Primary Insomnia

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

Primary Outcome Measures:
  • Patient-reported total sleep time.

Secondary Outcome Measures:
  • Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.

Estimated Enrollment: 520
Study Start Date: November 2005
Study Completion Date: October 2006
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266344

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00266344     History of Changes
Other Study ID Numbers: 2005_106, MK0928-040
Study First Received: December 14, 2005
Last Updated: October 28, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014