Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
This study has been completed.
Information provided by (Responsible Party):
First received: January 19, 2006
Last updated: April 14, 2015
Last verified: April 2015
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.
Sleep Initiation and Maintenance Disorders
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2007 (Final data collection date for primary outcome measure)
Other Name: GW679769
|Ages Eligible for Study:
||18 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00280423
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 19, 2006
||April 14, 2015
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 01, 2015
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs