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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• 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.

• No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.

• Use of nicotine, caffeine and alcoholic products.