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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092183 |
This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Nausea Vomiting Breast Neoplasms |
Drug: MK0869, aprepitant / Duration of Treatment: 3 days Drug: Comparator: ondansetron / Duration of Treatment: 3 days |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, 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 Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2004_063 |
Study First Received: | September 21, 2004 |
Last Updated: | June 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00092183 |
Health Authority: | United States: Food and Drug Administration |
Chemotherapy-Induced Nausea and Vomiting |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Skin Diseases Breast Neoplasms |
Nausea Ondansetron Serotonin Breast Diseases Aprepitant |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions Neoplasms |
Serotonin Antagonists Serotonin Agents Neoplasms by Site Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |