Status:
COMPLETED
Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime 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 determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Difficulty going to sleep and/or staying asleep during 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.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00354809
Start Date
May 1 2006
End Date
July 1 2007
Last Update
April 16 2015
Active Locations (24)
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1
GSK Investigational Site
Glendale, Arizona, United States, 85306
2
GSK Investigational Site
Glendale, California, United States, 91204
3
GSK Investigational Site
Hallandale, Florida, United States, 33009
4
GSK Investigational Site
Miami, Florida, United States, 33137