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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35213 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Phoenix |
| Arizona |
| 85050 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85712 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Burbank | California | 91506 | United States |
| GSK Investigational Site | Huntington Beach | California | 92648 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | San Diego | California | 92121 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | San Diego | California | 92161 | United States |
| GSK Investigational Site | San Francisco | California | 94105 | United States |
| GSK Investigational Site | Santa Rosa | California | 95405 | United States |
| GSK Investigational Site | Norwalk | Connecticut | 06850 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Delray Beach | Florida | 33484 | United States |
| GSK Investigational Site | Hallandale | Florida | 33009 | United States |
| GSK Investigational Site | Largo | Florida | 33773 | United States |
| GSK Investigational Site | Miami | Florida | 33143 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30328 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Gainesville | Georgia | 30501 | United States |
| GSK Investigational Site | Hinesville | Georgia | 31313 | United States |
| GSK Investigational Site | Macon | Georgia | 31201 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60634 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
| GSK Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Newton | Massachusetts | 02459 | United States |
| GSK Investigational Site | Troy | Michigan | 48085 | United States |
| GSK Investigational Site | Hattiesburg | Mississippi | 39404 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | West Seneca | New York | 14224 | United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| GSK Investigational Site | Beachwood | Ohio | 44122 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45227 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45246 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44130 | United States |
| GSK Investigational Site | Gallipolis | Ohio | 45631 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Gresham | Oregon | 97020 | United States |
| GSK Investigational Site | Clarks Summit | Pennsylvania | 18411 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Bellaire | Texas | 77401 | United States |
| GSK Investigational Site | Dallas | Texas | 75251 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| GSK Investigational Site | Calgary | Alberta | T2X 2A8 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5B4M4 | Canada |
| GSK Investigational Site | Niagara Falls | Ontario | L2G 1J4 | Canada |
| GSK Investigational Site | Parrry Sound | Ontario | P2A 1T3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4P 1P2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1E2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T3A9 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6J 3S3 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G5 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 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 |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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