Insomnia Clinical Trial
Official title:
A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.
| Verified date | April 2015 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 342 |
| Est. completion date | February 2007 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Mississauga | Ontario |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Niagara Falls | Ontario |
| Canada | GSK Investigational Site | Parrry Sound | Ontario |
| Canada | GSK Investigational Site | Sainte-Foy | Quebec |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Beachwood | Ohio |
| United States | GSK Investigational Site | Bellaire | Texas |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Burbank | California |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clarks Summit | Pennsylvania |
| United States | GSK Investigational Site | Clementon | New Jersey |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Crestview Hills | Kentucky |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Deland | Florida |
| United States | GSK Investigational Site | Delray Beach | Florida |
| United States | GSK Investigational Site | Duncansville | Pennsylvania |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | Gainesville | Georgia |
| United States | GSK Investigational Site | Gallipolis | Ohio |
| United States | GSK Investigational Site | Gresham | Oregon |
| United States | GSK Investigational Site | Hallandale Beach | Florida |
| United States | GSK Investigational Site | Hattiesburg | Mississippi |
| United States | GSK Investigational Site | Hinesville | Georgia |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Irvine | California |
| United States | GSK Investigational Site | Largo | Florida |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Macon | Georgia |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | National City | California |
| United States | GSK Investigational Site | Newton | Massachusetts |
| United States | GSK Investigational Site | Norwalk | Connecticut |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Overland Park | Kansas |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Plano | Texas |
| United States | GSK Investigational Site | Rockville | Maryland |
| United States | GSK Investigational Site | Salisbury | North Carolina |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Santa Rosa | California |
| United States | GSK Investigational Site | Stockbridge | Georgia |
| United States | GSK Investigational Site | Troy | Michigan |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Warwick | Rhode Island |
| United States | GSK Investigational Site | West Seneca | New York |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. | 28 Days | ||
| Secondary | Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. | 28 Days |
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