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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00266357
First received: December 14, 2005
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  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:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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
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 June 17, 2013