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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00539721

Enrollment

619

Registered

2007-10-04

Start date

2007-10-31

Completion date

2008-07-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea, Vomiting

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.

Interventions

DRUGRolapitant Dose 4

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

DRUGRolapitant Dose 3

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

DRUGRolapitant Dose 1

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

DRUGRolapitant Dose 2

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

DRUGOndansetron

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026