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This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 (casopitant) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of vomiting and retching | after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of nausea. Blood test results. | after surgery |
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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 |
|---|---|---|---|
| 21339433 | Background | Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKT102553 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Sheffield |
| Alabama |
| 35660 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Boynton Beach | Florida | 33437 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Naples | Florida | 34108 | United States |
| GSK Investigational Site | Pensacola | Florida | 32504 | United States |
| GSK Investigational Site | Anderson | Indiana | 46011 | United States |
| GSK Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | New Brunswick | New Jersey | 08901 | 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 | The Bronx | New York | 10467 | United States |
| GSK Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | San Antonio | Texas | 78240 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Edmonton | Alberta | T5H 3V9 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| GSK Investigational Site | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1L 3L5 | Canada |
| GSK Investigational Site | Regina | Saskatchewan | S4P 0W5 | Canada |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Caen | 14050 | France |
| GSK Investigational Site | Lyon | 69008 | France |
| GSK Investigational Site | Lyon | 69288 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Rennes | 35000 | France |
| GSK Investigational Site | Riom | 63204 | France |
| GSK Investigational Site | Strasbourg | 67098 cedex | France |
| 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 | Pokfulam | Hong Kong |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Győr | 9023 | Hungary |
| GSK Investigational Site | Miskolc | 3529 | Hungary |
| GSK Investigational Site | Szentes | 6600 | Hungary |
| GSK Investigational Site | Székesfehérvár | 8001 | Hungary |
| GSK Investigational Site | Dublin | Ireland |
| GSK Investigational Site | Galway | Ireland |
| GSK Investigational Site | Karachi | 74800 | Pakistan |
| GSK Investigational Site | Manila | 1003 | Philippines |
| GSK Investigational Site | Santa Cruz, Manila | 1003 | Philippines |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| GSK Investigational Site | Livingston | West Lothian | EH54 6PP | United Kingdom |
| GSK Investigational Site | Liverpool | L8 7SS | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102553 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and 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 |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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