Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia

This study has been completed.

First Received: January 21, 2005 Last Updated: July 31, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00102167

Purpose

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Condition	Intervention	Phase
Insomnia	Drug: gaboxadol	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, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:

Amount of time spent awake and time to fall asleep during one night [ Time Frame: one night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of deep sleep during one night. [ Time Frame: one night ] [ Designated as safety issue: No ]
Patient-reported sleep quality and awakenings during 1 night. [ Time Frame: one night ] [ Designated as safety issue: No ]

Enrollment:	663
Study Start Date:	February 2005
Study Completion Date:	December 2005

Intervention Details:

Duration of Treatment -1 day

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

Adults who are diagnosed with insomnia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102167

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 National Clinical Trials Identifier (NCT ID):

Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. Epub 2007 Aug 30.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_092, MK0928-006
Study First Received:	January 21, 2005
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00102167 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
Healthy
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