Clinical therapeutics
-
Clinical therapeutics · Mar 1999
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparison of an orally disintegrating ondansetron tablet with the conventional ondansetron tablet for cyclophosphamide-induced emesis in cancer patients: a multicenter, double-masked study. Ondansetron Orally Disintegrating Tablet Emesis Study Group.
A total of 427 cancer patients receiving cyclophosphamide chemotherapy participated in this multicenter, double-masked, double-dummy, parallel-group, randomized study comparing the antiemetic efficacy and safety of an 8-mg conventional ondansetron tablet (OT, n = 212) taken twice daily with an 8-mg orally disintegrating ondansetron tablet (ODT, n = 215) taken twice daily for 3 days. In the primary efficacy analysis, complete or major control of emesis (0 to 2 emetic episodes) between days 1 and 3 was seen in 80% of OT and 78% of ODT patients. The 90% confidence interval for the differences between treatments was -8.6% to 4.4% (defined interval of equivalence, +/-15%), showing that the formulations were equivalent. ⋯ The taste of ODT was acceptable to the majority of patients (89%) who received it. OT and ODT were both well tolerated. Thus 8 mg ODT twice daily represents a palatable, well-tolerated, and effective antiemetic treatment for the control of cyclophosphamide-induced emesis and nausea and provides equivalent treatment to OT 8 mg twice daily.
-
Clinical therapeutics · Mar 1999
Randomized Controlled Trial Multicenter Study Clinical TrialTreatment of menstruation-associated migraine with the nonprescription combination of acetaminophen, aspirin, and caffeine: results from three randomized, placebo-controlled studies.
This retrospective study sought to examine the benefits of the nonprescription combination of acetaminophen, aspirin, and caffeine (AAC; Excedrin Migraine, Bristol-Myers Squibb Company, New York, New York) for the treatment of menstruation-associated migraine compared with migraine not associated with menses. Data were derived from 3 double-masked, randomized, placebo-controlled, single-dose trials enrolling subjects who met the International Headache Society's diagnostic criteria for migraine with or without aura. Subjects with incapacitating disability (attacks requiring bed rest >50% of the time) and those who usually experienced vomiting > or =20% of the time were excluded. ⋯ The proportion of subjects who had 1 or more adverse experiences was significantly higher among those receiving AAC than among those receiving placebo (menstruation-associated migraine: AAC 26.4%, placebo 12.6%, P = 0.025; nonmenstruation-associated migraine: AAC 18.6%, placebo 11.4%, P = 0.005). Adverse experiences were similar in type and severity to those previously associated with single doses of acetaminophen, aspirin, or caffeine. Thus the nonprescription combination of AAC was highly effective in treating the pain, disability, and associated symptoms of both menstruation-associated migraine and migraine not associated with menses.