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Sponsored by: |
University of Navarre |
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Information provided by: | University of Navarre |
ClinicalTrials.gov Identifier: | NCT00450853 |
Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.
Condition | Intervention | Phase |
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Vomiting |
Drug: granisetron |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy |
Estimated Enrollment: | 25 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | March 2007 |
5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain, Navarra | |
Clinica Universitaria de Navarra | |
Pamplona, Navarra, Spain, 31008 |
Principal Investigator: | Alfonso Gurpide | Oncology Department. Clinica Universitaria de Navarra |
Study ID Numbers: | GRA / SC-IV |
Study First Received: | March 21, 2007 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00450853 |
Health Authority: | Spain: Spanish Agency of Medicines |
emesis granisetron pharmacokinetics subcutaneous. Prophylaxis of emesis in patients receiving platinum-based chemotherapy |
Vomiting 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 |