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

NCT ID: NCT00539721

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 619 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Rolapitant Dose 1

Group Type: EXPERIMENTAL

Rolapitant Dose 1

Intervention Type: DRUG

Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Rolapitant Dose 2

Group Type: EXPERIMENTAL

Rolapitant Dose 2

Intervention Type: DRUG

Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Rolapitant Dose 3

Group Type: EXPERIMENTAL

Rolapitant Dose 3

Intervention Type: DRUG

Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Rolapitant Dose 4

Group Type: EXPERIMENTAL

Rolapitant Dose 4

Intervention Type: DRUG

200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Ondansetron

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Interventions

Rolapitant Dose 1

Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Intervention Type: DRUG

Rolapitant Dose 2

Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Intervention Type: DRUG

Rolapitant Dose 3

Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Intervention Type: DRUG

Rolapitant Dose 4

200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Intervention Type: DRUG

Ondansetron

Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1

Intervention Type: DRUG

Placebo

Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia.
• Women whose postoperative hospitalization is expected to last at least 24 hours
• Women expected to require postoperative intravenous opioid PCA.
• Women whose surgery is expected to require at least 1 hour, but not more than 4 hours, of general anesthesia using the regimen defined in this protocol.
• Women of childbearing potential who have a negative pregnancy test or women who have been surgically sterilized or are postmenopausal.

Exclusion Criteria

• Women with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease.
• Women with a known hypersensitivity to ondansetron (or any other 5-HT3 antagonist), to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
• Women who are scheduled to undergo certain types of surgery.
• Women who are breastfeeding.
• Women who have retching/vomiting or moderate or severe nausea in the 24 hours prior to surgery or suffer from chronic nausea and/or vomiting.
• Women with a body mass index (BMI) >40.
• Women who have participated in a clinical trial of an investigational drug within 30 days prior to drug administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04937

Identifier Type: -

Identifier Source: org_study_id