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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

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.

• Nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.

• Use to moderate use of nicotine, caffeine and alcoholic products.