Phase III clinical studies with ondansetron (Qilu) in the prophylaxis of nausea and vomiting induced by non-cisplatin chemotherapy

Objective: This study was undertaken to further determine the clinical value of ondansetron (OND, supplied by Qilu Pharmaceutical Company) in the prophylaxis of nausea and vomiting induced by non-cisplatin chemotherapy. Methods: A total of 193 patients were enrolled in the multicenter prospective study and were given treatment of non-cisplatin based chemotherapy. All patients were treated with OND 8 mg iv once a day during chemotherapy, followed by OND 4mg orally twice a day for one day after chemotherapy. Results: The effective control rate (0-2 emetic episodes) on the first day was 93.3%. Total control of delayed vomiting (day 2-5) was as high as 94.8 to 99.5%. The mean frequency of vomiting was 0. 4, 0. 4, 0.2, 0. 1 and 0. 1, respectively from day 1 to day 5. Adverse effects were minor and tolerable. Conclusion: This modified regimen of treatment with OND is effective in the control of vomiting induced by non-DDP chemotherapy.