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Sponsored by: |
Xijing Hospital |
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Information provided by: | Xijing Hospital |
ClinicalTrials.gov Identifier: | NCT00666783 |
This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.
Condition | Intervention | Phase |
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Chemotherapy-Induced Nausea and Vomiting |
Drug: palonosetron Drug: Granisetron |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients |
Enrollment: | 208 |
Arms | Assigned Interventions |
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PAL: Experimental
receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
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Drug: palonosetron
receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.
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GRA: Active Comparator
receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
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Drug: Granisetron
receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Clinical trial center of Xijing Hospital ( Xijing Hospital ) |
Study ID Numbers: | 2006L01595 |
Study First Received: | April 23, 2008 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00666783 |
Health Authority: | China: the State Food and Drug Administration |
Signs and Symptoms Palonosetron Vomiting Signs and Symptoms, Digestive |
Nausea Granisetron Serotonin |
Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Therapeutic Uses |
Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |