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

October 8, 2013 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

619

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Experimental: Rolapitant Dose 1
Drug: Rolapitant Dose 1
Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Experimental: Rolapitant Dose 2
Drug: Rolapitant Dose 2
Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Experimental: Rolapitant Dose 3
Drug: Rolapitant Dose 3
Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Experimental: Rolapitant Dose 4
Drug: Rolapitant Dose 4
200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Active Comparator: Ondansetron
Drug: Ondansetron
Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No emetic episodes regardless of rescue medication use.
Time Frame: First 24 hours after surgery.
First 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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