Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

Phase 2

Completed

• Conditions: Insomnia; Sleep Initiation and Maintenance Disorders

• Registration Number: NCT00280436
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

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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.
• Nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
• Use to moderate use of nicotine, caffeine and alcoholic products.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparison of GW679769 and placebo on the average time needed to fall asleep after bedtime dosing on two consecutive nights, as assessed by electroencephalography and other physiological changes during sleep.	48 Hours

Secondary Outcome Measures

Name	Time	Method
Comparison of GW679769 and placebo on sleep maintenance and duration after bedtime dosing on two consecutive nights, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.	48 Hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Fairfax, Virginia, United States