Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

This study has been completed.

First Received: January 19, 2006 Last Updated: March 26, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00280423

Purpose

This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Condition	Intervention	Phase
Insomnia	Drug: GW679769	Phase II

Drug Information available for: Casopitant mesylate GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. [ Time Frame: 28 Days ]

Secondary Outcome Measures:

Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. [ Time Frame: 28 Days ]

Enrollment:	321
Study Start Date:	January 2006

Eligibility

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

Criteria

Inclusion Criteria:

Difficulty going to sleep and/or staying asleep for at least the past 3 months.
Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria:

History of other sleep disorders such as sleep apnea or restless leg syndrome.
Regular sleep habits, including bedtime between 9 PM and midnight.
No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
Use of nicotine, caffeine and alcoholic products.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280423

Show 71 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	MAD103894
Study First Received:	January 19, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00280423 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Primary Insomnia
Electroencephalography
Polysomnography
Sleep
Cognition

Study placed in the following topic categories:

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 May 07, 2009