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

A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280423

Enrollment

342

Registered

2006-01-23

Start date

2006-01-31

Completion date

2007-02-28

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders, Insomnia

Keywords

Cognition, Polysomnography, Primary Insomnia, Electroencephalography, Sleep

Brief summary

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.

Interventions

DRUGGW679769

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	28 Days

Secondary

Measure	Time frame
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.	28 Days

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026