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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 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 when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. | 9 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment. | 9 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 | Glendale | Arizona | 85306 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Glendale |
| California |
| 91204 |
| United States |
| GSK Investigational Site | Hallandale | Florida | 33009 | United States |
| GSK Investigational Site | Miami | Florida | 33137 | United States |
| GSK Investigational Site | Fayetteville | Georgia | 30214 | United States |
| GSK Investigational Site | Hinesville | Georgia | 31313 | United States |
| GSK Investigational Site | Suwanee | Georgia | 30024 | United States |
| GSK Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | United States |
| GSK Investigational Site | Newton | Massachusetts | 02459 | United States |
| GSK Investigational Site | Fayetteville | North Carolina | 28304 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Clamart | 92140 | France |
| GSK Investigational Site | Paris | 75181 | France |
| GSK Investigational Site | Rouffach | 68250 | France |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Schwalmstadt | Hesse | 34613 | Germany |
| GSK Investigational Site | Göttingen | Lower Saxony | 37075 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19053 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10559 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14050 | Germany |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 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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