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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Sleep Initiation and Maintenance Disorders

Insomnia

Treatments

Drug: GW679769

Study type

Interventional

Funder types

Industry

Identifiers

NCT00280423

MAD103894

Details and patient eligibility

About

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.

Enrollment

342 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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.