A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00650871

Purpose

A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.

Condition	Intervention	Phase
Insomnia	Drug: GW679769 Drug: Placebo	Phase II

Drug Information available for: GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of GW679769 (30mg and 90mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Wake time after sleep onset (WASO) derived from polysomnographic (PSG) recording

Secondary Outcome Measures:

PSG Total Sleep Time (TST), latency to persistent sleep, and number of awakenings. Subject related TST, WASO, Sleep Onset Latency. Morning tests of alertness, memory and fine motor control. Blood levels of GW679769; 2 samples at each treatment visit.

Enrollment:	48
Study Start Date:	July 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Healthy male and female subjects with primary insomnia with normal EG may be eligible for inclusion.

Exclusion Criteria:

clinically significant physical or psychiatric illness or abnormal sleep patterns.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650871

Locations

United States, California
GSK Investigational Site
San Diego, California, United States, 92123
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, New York
GSK Investigational Site
New York, New York, United States, 10025
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
GSK Investigational Site
Durham, North Carolina, United States
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	GW679769/903
Study First Received:	March 31, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00650871
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW679769,
sleep,
cognitive function,
primary insomnia,
polysomnography.

Study placed in the following topic categories:

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