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An Investigational Study of MK0928 in Adult Outpatients With Insomnia

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00103818
First received: February 15, 2005
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).


Condition Intervention Phase
Insomnia
 Drug: gaboxadol
Drug: Comparator: placebo (unspecified)
 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-Group Efficacy Study of MK0928 15 mg and 10 mg 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 asleep at night after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported awakenings at night [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Functioning after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: February 2005
Study Completion Date: October 2006
Intervention Details:
    Drug: gaboxadol
    Duration of Treatment: 3 months
    Other Name: MK0928
    Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 3 months
  Eligibility

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

Inclusion Criteria:

  • Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who do not have a diagnosis of insomnia (a sleep disorder)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103818

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: NCT00103818     History of Changes
Other Study ID Numbers: 2005_002, MK0928-014
Study First Received: February 15, 2005
Last Updated: January 25, 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 June 13, 2013