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This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous ondansetron | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia | ||
| The extent of nausea experienced by subjects. |
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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 | Montgomery | Alabama | 36106 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20526194 | Background | Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010 Jul;113(1):74-82. doi: 10.1097/ALN.0b013e3181d7b13a. |
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| Phoenix |
| Arizona |
| 85032 |
| United States |
| GSK Investigational Site | Arcadia | California | 91007 | United States |
| GSK Investigational Site | Duarte | California | 91010 | United States |
| GSK Investigational Site | Glendale | California | 91206 | United States |
| GSK Investigational Site | Laguna Hills | California | 92653 | United States |
| GSK Investigational Site | Loma Linda | California | 92354 | United States |
| GSK Investigational Site | Pasadena | California | 91109 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Stanford | California | 94305 | United States |
| GSK Investigational Site | Naples | Florida | 34108 | United States |
| GSK Investigational Site | Pensacola | Florida | 32504 | United States |
| GSK Investigational Site | Alpharetta | Georgia | 30005 | United States |
| GSK Investigational Site | Hutchinson | Kansas | 67502 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70806 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21229-5299 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | New Brunswick | New Jersey | 8903 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10025 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Houston | Texas | 77024 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | San Antonio | Texas | 78240 | United States |
| GSK Investigational Site | Winchester | Virginia | 22601 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | Aalst | 9300 | Belgium |
| GSK Investigational Site | Braasschaat | 2930 | Belgium |
| GSK Investigational Site | Brussels | 1020 | Belgium |
| GSK Investigational Site | Calgary | Alberta | T2N 2T9 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T5H 3V9 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 3C6 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| GSK Investigational Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Investigational Site | London | Ontario | N6A 4G5 | Canada |
| GSK Investigational Site | London | Ontario | N6A 4V2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 2S8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| GSK Investigational Site | Québec | Quebec | G1L 3L5 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| GSK Investigational Site | Ste-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Marburg | Hesse | 35043 | Germany |
| GSK Investigational Site | Aachen | North Rhine-Westphalia | 52074 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56073 | Germany |
| GSK Investigational Site | Győr | 9023 | Hungary |
| GSK Investigational Site | Kistarcsa | 2143 | Hungary |
| GSK Investigational Site | Miskolc | 3529 | Hungary |
| GSK Investigational Site | Székesfehérvár | 8001 | Hungary |
| GSK Investigational Site | Cadiz | 11009 | Spain |
| GSK Investigational Site | Cartagena | 30203 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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