Comparison of an orally disintegrating ondansetron tablet with the conventional ondansetron tablet for cyclophosphamide-induced emesis in cancer patients: A multicenter, double-masked study

A total of 427 cancer patients receiving cyclophosphamide chemotherapy part icipated in this multicenter, double-masked, douple-dummy, parallel-group, randomized-study comparing the antiemetic efficacy and safety of an 8-mg co nventional ondansetron tablet (OT, n = 212) taken twice daily with an 8-mg orally disintegrating ondansetron tablet (ODT, n = 215) taken twice daily f or 3 days. In the primary efficacy analysis, complete or major control of e mesis (0 to 2 emetic episodes) between days I and 3 was seen in 80% of OT a nd 78% of ODT patients. The 90% confidence interval for the differences bet ween treatments was -8.6% to 4.4% (de-fined interval of equivalence, +/-15% ), showing that the formulations were equivalent. In the secondary efficacy analysis, no significant differences were observed in the rates of complet e control of emesis (no episodes of emesis) over 3 days (63% and 64% of the respective groups) and on day 1 (84% and 81%, respectively) and in the com plete control of nausea over 3 days (37% and 43%, respectively) and on day 1 (59% and 61% of patients, respectively). The taste of ODT was acceptable to the majority of patients (89%) who received it. OT and ODT were both wel l tolerated. Thus 8 mg ODT twice daily represents a palatable, well-tolerat ed, and effective antiemetic treatment for the control of cyclophosphamide- induced emesis and nausea and provides equivalent treatment to OT 8 mg twic e daily.