Chemotherapy-Induced Nausea and Vomiting Clinical Trial
Official title:
A Phase II Multicenter, Randomized, Double-blind, Placebo-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
Verified date | April 2015 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
Status | Completed |
Enrollment | 722 |
Est. completion date | January 2006 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. - Diagnosed with a solid malignant tumor and has not previously received chemotherapy. - Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria: - Not received any investigational product within 30 days of enrollment into the study. - Must not be pregnant. - Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. - Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. - Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). - Must not have a history of peptic ulcer disease. |
Country | Name | City | State |
---|---|---|---|
Argentina | GSK Investigational Site | Capital Federal | Buenos Aires |
Argentina | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | |
Austria | GSK Investigational Site | Salzburg | |
Austria | GSK Investigational Site | Vienna | |
Austria | GSK Investigational Site | Vienna | |
Canada | GSK Investigational Site | Charlottetown | Prince Edward Island |
Canada | GSK Investigational Site | Greenfield Park | Quebec |
Canada | GSK Investigational Site | Kitchener | Ontario |
Canada | GSK Investigational Site | Oshawa | Ontario |
Canada | GSK Investigational Site | Québec | Quebec |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Croatia | GSK Investigational Site | Osijek | |
Czech Republic | GSK Investigational Site | Hradec Kralove | |
Czech Republic | GSK Investigational Site | Ostrava - Poruba | |
Czech Republic | GSK Investigational Site | Praha 10 | |
Czech Republic | GSK Investigational Site | Praha 5 | |
Czech Republic | GSK Investigational Site | Praha 8 | |
Germany | GSK Investigational Site | Essen | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Muenchen | Bayern |
Germany | GSK Investigational Site | Regensburg | Bayern |
Greece | GSK Investigational Site | Athens | |
Greece | GSK Investigational Site | Haidari | |
Greece | GSK Investigational Site | Thessaloniki | |
Hong Kong | GSK Investigational Site | Pokfulam | |
Hungary | GSK Investigational Site | Budapest | |
Hungary | GSK Investigational Site | Mátraháza | |
Ireland | GSK Investigational Site | Dublin | |
Ireland | GSK Investigational Site | Dublin | |
Ireland | GSK Investigational Site | Dublin | |
Ireland | GSK Investigational Site | Dublin | |
Ireland | GSK Investigational Site | Tallaght, Dublin | |
Ireland | GSK Investigational Site | Tullamore | |
Mexico | GSK Investigational Site | Durango | |
Mexico | GSK Investigational Site | Merida | Yucatán |
Pakistan | GSK Investigational Site | Karachi | |
Pakistan | GSK Investigational Site | Lahore | |
Philippines | GSK Investigational Site | Quezon City | |
Philippines | GSK Investigational Site | Taft Avenue, Manila | |
Poland | GSK Investigational Site | Kielce | |
Poland | GSK Investigational Site | Olsztyn | |
Poland | GSK Investigational Site | Opole | |
Poland | GSK Investigational Site | Szczecin | |
Portugal | GSK Investigational Site | Lisboa | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow Region | |
Singapore | GSK Investigational Site | Singapore | |
Slovakia | GSK Investigational Site | Bratislava | |
Slovakia | GSK Investigational Site | Zilina | |
Spain | GSK Investigational Site | Madrid | |
Spain | GSK Investigational Site | Marid | |
Spain | GSK Investigational Site | Pontevedra | |
Spain | GSK Investigational Site | Valencia | |
Taiwan | GSK Investigational Site | Tainan | |
Taiwan | GSK Investigational Site | Taipei | |
Taiwan | GSK Investigational Site | Taipei | |
Thailand | GSK Investigational Site | Bangkok | |
Thailand | GSK Investigational Site | Chiang Mai | |
United Kingdom | GSK Investigational Site | Cardiff | Glamorgan |
United Kingdom | GSK Investigational Site | Chelmsford | Essex |
United Kingdom | GSK Investigational Site | Edinburgh | Midlothian |
United Kingdom | GSK Investigational Site | Exeter | Devon |
United Kingdom | GSK Investigational Site | Shrewsbury | |
United States | GSK Investigational Site | Abingdon | Virginia |
United States | GSK Investigational Site | Akron | Ohio |
United States | GSK Investigational Site | Alexandria | Louisiana |
United States | GSK Investigational Site | Baton Rouge | Louisiana |
United States | GSK Investigational Site | Bay City | Michigan |
United States | GSK Investigational Site | Bethesda | Maryland |
United States | GSK Investigational Site | Birmingham | Alabama |
United States | GSK Investigational Site | Bismarck | North Dakota |
United States | GSK Investigational Site | Boynton Beach | Florida |
United States | GSK Investigational Site | Bronx | New York |
United States | GSK Investigational Site | Burlington | Vermont |
United States | GSK Investigational Site | Canton | Ohio |
United States | GSK Investigational Site | Centralia | Illinois |
United States | GSK Investigational Site | Corona | California |
United States | GSK Investigational Site | Corpus Christi | Texas |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Everett | Washington |
United States | GSK Investigational Site | Greenbrae | California |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Hudson | Florida |
United States | GSK Investigational Site | Hutchinson | Kansas |
United States | GSK Investigational Site | Jefferson City | Missouri |
United States | GSK Investigational Site | Lakewood | Colorado |
United States | GSK Investigational Site | Loma Linda | California |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Muncie | Indiana |
United States | GSK Investigational Site | New Albany | Indiana |
United States | GSK Investigational Site | Ocala | Florida |
United States | GSK Investigational Site | Ogden | Utah |
United States | GSK Investigational Site | Palm Springs | California |
United States | GSK Investigational Site | Park Ridge | Illinois |
United States | GSK Investigational Site | Rhinelander | Wisconsin |
United States | GSK Investigational Site | Richmond | Virginia |
United States | GSK Investigational Site | Rochester | New York |
United States | GSK Investigational Site | Rolla | Missouri |
United States | GSK Investigational Site | Skokie | Illinois |
United States | GSK Investigational Site | Sparta | New Jersey |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | Sumter | South Carolina |
United States | GSK Investigational Site | Tacoma | Washington |
United States | GSK Investigational Site | Tacoma | Washington |
United States | GSK Investigational Site | Tupelo | Mississippi |
United States | GSK Investigational Site | Tyler | Texas |
United States | GSK Investigational Site | West Point | Utah |
United States | GSK Investigational Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Argentina, Austria, Canada, Chile, Croatia, Czech Republic, Germany, Greece, Hong Kong, Hungary, Ireland, Mexico, Pakistan, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Taiwan, Thailand, United Kingdom,
Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy. | |||
Secondary | Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits. |
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