Safety of MK0928 on Insomnia in the Elderly - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00095043

Purpose

The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

Condition	Intervention	Phase
Insomnia	Drug: MK0928, gaboxadol Drug: Comparator: placebo	Phase III

Drug Information available for: Gaboxadol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK-0928 in the Treatment of Elderly Outpatients With Primary Insomnia

Further study details as provided by Merck:

Primary Outcome Measures:

Secondary Outcome Measures:

Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire

Estimated Enrollment:	320
Study Start Date:	October 2004

Detailed Description:

The duration of treatment is 1 year.

Eligibility

Criteria

Inclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095043

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Study ID Numbers:	2004_088
Study First Received:	October 29, 2004
Last Updated:	July 6, 2006
ClinicalTrials.gov Identifier:	NCT00095043
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