NCT00539721 - A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED) | Biotech Hunter

Enrollment

619

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions

Postoperative Nausea and Vomiting

Interventions

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

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY