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)

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

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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.

Overall Status Completed
Start Date October 2007
Completion Date July 2008
Primary Completion Date July 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
No emetic episodes regardless of rescue medication use. First 24 hours after surgery.
Enrollment 619
Condition
Intervention

Intervention type: Drug

Intervention name: Rolapitant Dose 1

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

Arm group label: Rolapitant Dose 1

Intervention type: Drug

Intervention name: Rolapitant Dose 2

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

Arm group label: Rolapitant Dose 2

Intervention type: Drug

Intervention name: Rolapitant Dose 3

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

Arm group label: Rolapitant Dose 3

Intervention type: Drug

Intervention name: Rolapitant Dose 4

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

Arm group label: Rolapitant Dose 4

Intervention type: Drug

Intervention name: Ondansetron

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

Arm group label: Ondansetron

Intervention type: Drug

Intervention name: Placebo

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

Arm group label: Placebo

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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Verification Date

October 2013

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Arm group label: Rolapitant Dose 1

Arm group type: Experimental

Arm group label: Rolapitant Dose 2

Arm group type: Experimental

Arm group label: Rolapitant Dose 3

Arm group type: Experimental

Arm group label: Rolapitant Dose 4

Arm group type: Experimental

Arm group label: Ondansetron

Arm group type: Active Comparator

Arm group label: Placebo

Arm group type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov