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Efficacy and Safety of MK0928 for Insomnia in Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00095069
First received: October 29, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.


Condition Intervention Phase
Insomnia
 Drug: MK0928, gaboxadol / Duration of Treatment - 1 year
Drug: Comparator: placebo / Duration of Treatment -1 year
 Phase 3

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: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:
  • Patient-reported amount of sleep and time to fall sleep at night after three months

Secondary Outcome Measures:
  • Patient-reported awakenings at night
  • Sleep quality
  • Functioning after 3 months

Estimated Enrollment: 600
Study Start Date: October 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of insomnia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095069

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00095069     History of Changes
Other Study ID Numbers: 2004_086, MK0928-003
Study First Received: October 29, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

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 May 21, 2013