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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00366834 |
This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Nausea Vomiting |
Drug: Casopitant (GW679769) oral tablets Drug: Casopitant (GW679769) intravenous Drug: Dexamethasone intravenous Drug: Ondansetron oral tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Enrollment: | 1840 |
Study Start Date: | July 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Hematologic and metabolic status must be adequate for receiving a moderately emetogenic regimen and meet the following criteria:
Liver enzymes must be below the following limits:
Women of childbearing potential; must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Cycle 1, Day 1 and agrees to one of the following:
Exclusion criteria:
Has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drug. This includes, but is not limited to:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NKV102549 |
Study First Received: | August 17, 2006 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00366834 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Anthracycline Cyclophosphamide Moderately |
Emetogenic Nausea Vomiting |
Dexamethasone Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nausea |
Ondansetron Cyclophosphamide Serotonin Dexamethasone acetate |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Antiemetics Hormones Serotonin Antagonists Therapeutic Uses Antipruritics Dermatologic Agents |
Tranquilizing Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Glucocorticoids Pharmacologic Actions Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |