NCT00539721

A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)

A Randomized, Double-Blind, Double-Dummy, Dose-Ranging, Active- and Placebo-Controlled Study of Single-Dose Oral Rolapitant Monotherapy for the Prevention of Postoperative Nausea and Vomiting (PONV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled study in women who are having elective open abdominal surgery with general anesthesia and who are expected to need patient-controlled analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting in the first 24 hours after surgery. Participation in the study may last up to 3 months. The total duration of the study will be approximately 36 weeks.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Rolapitant Dose 1	Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
DRUG	Rolapitant Dose 2	Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
DRUG	Rolapitant Dose 3	Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
DRUG	Rolapitant Dose 4	200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
DRUG	Ondansetron	Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
DRUG	Placebo	Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-10-04
• Last updated: 2013-11-01