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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00169572 |
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.
Condition | Intervention | Phase |
---|---|---|
Nausea and Vomiting Chemotherapy-Induced |
Drug: Aprepitant Drug: Ondansetron Drug: GW679769 Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 492 |
Study Start Date: | February 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NKV20001 |
Study First Received: | September 9, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00169572 |
Health Authority: | Italy: The Italian Medicines Agency |
Nausea Vomiting Emesis Chemotherapy-induced Nausea and Vomiting CINV |
Dexamethasone Signs and Symptoms Vomiting Cisplatin Signs and Symptoms, Digestive |
Nausea Ondansetron Serotonin Dexamethasone acetate Aprepitant |
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 |