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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00090207 |
Purpose
A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea Vomiting |
Drug: MK0869, aprepitant / Duration of Treatment: 3 days Drug: Comparator: ondansetron / Duration of Treatment: 4 days |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2004_005, MK0869-801 |
| Study First Received: | August 25, 2004 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00090207 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Antiemetics Signs and Symptoms Serotonin Antagonists Therapeutic Uses Antipruritics Nausea Ondansetron |
Dermatologic Agents Aprepitant Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |