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The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia. | 72 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia. | 120 Hours |
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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 | San Francisco | California | 94115 | United States | ||
| GSK Investigational Site |
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| Melbourne |
| Florida |
| 32901 |
| United States |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Grand Rapids | Michigan | 49525 | United States |
| GSK Investigational Site | Royal Oak | Michigan | 48073 | United States |
| GSK Investigational Site | Camden | New Jersey | 08103-1489 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| GSK Investigational Site | Copenhagen | 2100 Ø | Denmark |
| GSK Investigational Site | Glostrup Municipality | 2600 | Denmark |
| GSK Investigational Site | Viborg | 8800 | Denmark |
| GSK Investigational Site | Lai Chi Kok | Hong Kong |
| GSK Investigational Site | Pokfulam | Hong Kong |
| GSK Investigational Site | Shamshuipo, Kowloon | Hong Kong |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Tuenmen | Hong Kong |
| GSK Investigational Site | Budapest | 1115 | Hungary |
| GSK Investigational Site | Budapest | 1124 | Hungary |
| GSK Investigational Site | Szentes | 6600 | Hungary |
| GSK Investigational Site | Kfar Saba | 44281 | Israel |
| GSK Investigational Site | Tel Litwinsky | 52621 | Israel |
| GSK Investigational Site | Gjettum | N-1346 | Norway |
| GSK Investigational Site | Oslo | N-0407 | Norway |
| GSK Investigational Site | Skien | N-3710 | Norway |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Manila | 1003 | Philippines |
| GSK Investigational Site | Ljubljana | SI-1000 | Slovenia |
| GSK Investigational Site | Novo Mesto | 8000 | Slovenia |
| GSK Investigational Site | Slovenj Gradec | 2380 | Slovenia |
| GSK Investigational Site | Badalona(Barcelona) | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Pamplona | 31008 | Spain |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Glasgow | Lanarkshire | G11 6NT | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G42 9TY | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G51 4TF | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH16 4SA | United Kingdom |
| GSK Investigational Site | Livingston | West Lothian | EH54 6PP | United Kingdom |
| GSK Investigational Site | Hull | HU16 5JD | United Kingdom |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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