Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of GW679769 and placebo on the average time needed to fall asleep after bedtime dosing on two consecutive nights, as assessed by electroencephalography and other physiological changes during sleep. | 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of GW679769 and placebo on sleep maintenance and duration after bedtime dosing on two consecutive nights, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. | 48 Hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85050 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 6, 2017 | |
| Unrelease | Aug 15, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Tucson |
| Arizona |
| 85710 |
| United States |
| GSK Investigational Site | Anaheim | California | 92805 | United States |
| GSK Investigational Site | Glendale | California | 91204 | United States |
| GSK Investigational Site | Glendale | California | 91206 | United States |
| GSK Investigational Site | Redlands | California | 92373 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Kissimmee | Florida | 34741 | United States |
| GSK Investigational Site | Naples | Florida | 34110 | United States |
| GSK Investigational Site | Spring Hill | Florida | 34609 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Chicago | Illinois | 60634 | United States |
| GSK Investigational Site | Northfield | Illinois | 60093 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
| GSK Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| GSK Investigational Site | Frederick | Maryland | 21702 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68510 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Lafayette Hill | Pennsylvania | 19444 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Anderson | South Carolina | 29621 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Fairfax | Virginia | 22030 | United States |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 6, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C531951 | casopitant |
Not provided
Not provided
Not provided