Elderly Primary Insomnia Polysomnographic Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00094666

Purpose

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

Condition	Intervention	Phase
Primary Insomnia	Drug: MK0928, gaboxadol / Duration of Treatment - 6 weeks Drug: Comparator: placebo / Duration of Treatment - 6 weeks	Phase III

Drug Information available for: Gaboxadol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	465
Study Start Date:	November 2004

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094666

Locations

United States, Florida
Call for Information
Hallandale Beach, Florida, United States, 33009
United States, New York
Call for Information
Williamsville, New York, United States, 14221

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications indexed to this study:

Study ID Numbers:	2004_085
Study First Received:	October 21, 2004
Last Updated:	March 28, 2007
ClinicalTrials.gov Identifier:	NCT00094666
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:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009