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Adult Primary Insomnia Polysomnographic Study
This study has been completed.
First Received: October 21, 2004   Last Updated: April 27, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00094627
  Purpose

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.


Condition Intervention Phase
Primary Insomnia
 Drug: gaboxadol
Drug: Comparator: placebo (unspecified)
 Phase III

Drug Information available for: Gaboxadol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:
  • Amount of time spent awake and time to fall asleep at night after 2 days [ Time Frame: After 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of time spent awake and time to fall asleep at night after 30 days [ Time Frame: After 30 days ] [ Designated as safety issue: No ]
  • Amount of deep sleep after 2 days [ Time Frame: After 2 days ] [ Designated as safety issue: No ]

Enrollment: 465
Study Start Date: November 2004
Study Completion Date: April 2006
Intervention Details:
    Drug: gaboxadol
    Duration of Treatment - 6 weeks
    Drug: Comparator: placebo (unspecified)
    Duration of Treatment - 6 weeks
  Eligibility

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

Inclusion Criteria:

  • Adult patients with a diagnosis of primary insomnia and in good physical and mental health

Exclusion Criteria:

  • Adult patients with other medical , neurological and sleep disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094627

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

Publications:
Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct 1;31(10):1359-70.

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_087, MK0928-004
Study First Received: October 21, 2004
Last Updated: April 27, 2009
ClinicalTrials.gov Identifier: NCT00094627     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Sleep Initiation and Maintenance Disorders
Mental Disorders
 Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

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

ClinicalTrials.gov processed this record on May 07, 2009



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