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This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | |||
| Ondansetron | Drug | |||
| GW679769 | Drug | |||
| Dexamethasone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Capital Federal | Buenos Aires | C1437JCP | Argentina | ||
| GSK Investigational Site |
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| Buenos Aires |
| C1405CBA |
| Argentina |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Vienna | A-1130 | Austria |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Liège | 4020 | Belgium |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500921 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Zagreb | 10000 | Croatia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Ostrava - Poruba | 708 52 | Czechia |
| GSK Investigational Site | Prague | 12808 | Czechia |
| GSK Investigational Site | Prague | 154 00 | Czechia |
| GSK Investigational Site | Prague | 180 81 | Czechia |
| GSK Investigational Site | Shatin, N.T. | Hong Kong |
| GSK Investigational Site | Budapest | 1529 | Hungary |
| GSK Investigational Site | Székesfehérvár | 8000 | Hungary |
| GSK Investigational Site | Benevento | Campania | 82100 | Italy |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | Rome | Lazio | 00149 | Italy |
| GSK Investigational Site | Rome | Lazio | 00184 | Italy |
| GSK Investigational Site | Casalpusterlengo (LO) | Lombardy | 26841 | Italy |
| GSK Investigational Site | Sassari | Sardinia | 07100 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | Perugia | Umbria | 06156 | Italy |
| GSK Investigational Site | Durango | Durango | 34000 | Mexico |
| GSK Investigational Site | Mérida | Yucatán | 97500 | Mexico |
| GSK Investigational Site | Amsterdam | 1066 CX | Netherlands |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| GSK Investigational Site | Arnhem | 6815 AD | Netherlands |
| GSK Investigational Site | Rotterdam | 3045 PM | Netherlands |
| GSK Investigational Site | Utrecht | 3527 CE | Netherlands |
| GSK Investigational Site | Karachi | 54000 | Pakistan |
| GSK Investigational Site | Lahore | Pakistan |
| GSK Investigational Site | Callao | Provincia Constitucional del Callao | Callao 1 | Peru |
| GSK Investigational Site | Quezon City | 1101 | Philippines |
| GSK Investigational Site | Taft Avenue, Manila | 1700 | Philippines |
| GSK Investigational Site | Bydogoszcz | 85-796 | Poland |
| GSK Investigational Site | Krakow | 31-115 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Poznan | 61-866 | Poland |
| GSK Investigational Site | Bucharest | 022328 | Romania |
| GSK Investigational Site | Singapore | 119074 | Singapore |
| GSK Investigational Site | Košice | 041 90 | Slovakia |
| GSK Investigational Site | Nitra | 949 88 | Slovakia |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Taipei | 114 | Taiwan |
| GSK Investigational Site | Tao Yuan County | 333 | Taiwan |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D017294 | Ondansetron |
| C531951 | casopitant |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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