A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron and Dexamethasone for the Prevention of Nausea

简要总结

详细描述

主要结局

次要结局

• Maximum nausea score (to assess the severity of nausea), as assessed by a Visual Analogue Scale (VAS) over the first 120 hours and in the acute and delayed phases following each cycle of MEC.(approx. 18 mos)
• Time to first antiemetic rescue medication, defined as the time elapsed from the start of administration of the MEC regimen to the first use of antiemetic rescue medication.(approx. 18 mos)
• Complete response over 120 hours following subsequent chemotherapy cycles Use of rescue medication over 120 hours following all chemotherapy cycles Impact on daily life activities over 120 hours, assessed using a subject diary questionnaire(120 Hours)
• The proportion of subjects who achieve a complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of MEC.(approx. 18 mos)
• The proportion of subjects who achieve a complete response over the first 120 hours, during the acute (0-24 hours), the delayed (24-120 hours), and the overall (0-120 hours) phase following subsequent cycles of MEC.(approx. 18 mos)
• If a subject withdraws prematurely during the first 120 hours, then the time of withdrawal will be considered to be their time to first use of antiemetic rescue medication, and will be censored.(approx. 18 mos)
• Time to first emetic event, defined as the time elapsed from the start of administration of the MEC regimen to the first emetic episode. If a subject withdraws prematurely during the first 120 hours,(approx. 18 mos)
• then the time of withdrawal will be considered to be their time to first emetic episode, and will be censored.(approx. 18 mos)
• The proportion of subjects who receive rescue medication.(approx. 18 mos)
• The proportion of subjects reporting significant nausea defined as a maximum nausea score greater than or equal to 25 mm on the VAS.(approx. 18 mos)
• The proportion of subjects reporting nausea defined as a maximum nausea score greater than or equal to 5 mm on the VAS.(approx. 18 mos)
• The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.(approx. 18 mos)
• The impact on subjects' daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the FLIE questionnaire.(approx. 18 mos)
• Subject satisfaction with the prophylactic antiemetic regimens, and the willingness of subjects to use the same treatment during future chemotherapy, as assessed by the Subject Satisfaction\Willingness Assessment in the Subject Diary.(approx. 18 mos)
• Nausea as assessed by a categorical scale, over the first 120 hours following MEC administration.(approx. 18 mos)
• Assessment of the safety and tolerability of casopitant through: routine physical exam, routine clinical laboratory tests, clinical monitoring and adverse events reporting.(approx. 18 mos)
• The proportion of subjects who vomit/retch.(approx. 18 mos)
• The proportion of subjects achieving total control, defined as complete responders who had no nausea.(approx. 18 mos)