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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00687011 |
The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.
Condition | Intervention | Phase |
---|---|---|
Neoplasms Nausea Vomiting |
Drug: Palonosetron and Dexamethasone |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Open-Label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-Induced Nausea and Vomit (CINV). |
Estimated Enrollment: | 110 |
Study Start Date: | January 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Palonosetron-dexamethasone: Experimental |
Drug: Palonosetron and Dexamethasone
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04594 |
Study First Received: | May 27, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00687011 |
Health Authority: | Mexico: Ministry of Health |
Antiemetic |
Dexamethasone Signs and Symptoms Palonosetron Vomiting Signs and Symptoms, Digestive |
Methylprednisolone Nausea Serotonin Dexamethasone acetate |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Glucocorticoids |
Hormones Pharmacologic Actions Serotonin Antagonists Neoplasms Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |