An Investigational Study of MK0928 in Adult Outpatients With Insomnia - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00103818

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Gaboxadol

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 ]

Intervention Details:

Duration of Treatment: 3 months

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_002, MK0928-014
Study First Received:	February 15, 2005
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00103818 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 September 11, 2009