Status:
COMPLETED
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sleep Initiation and Maintenance Disorders
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 impairmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00280423
Start Date
January 1 2006
End Date
February 1 2007
Last Update
April 15 2015
Active Locations (71)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35213
2
GSK Investigational Site
Phoenix, Arizona, United States, 85050
3
GSK Investigational Site
Tucson, Arizona, United States, 85712
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205