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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539721
• Other study ID #: P04937
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2007
• Last updated: October 8, 2013
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: October 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Rolapitant Dose 1
Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
• Rolapitant Dose 2
Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
• Rolapitant Dose 3
Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
• Rolapitant Dose 4
200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
• Ondansetron
Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
• Placebo
Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No emetic episodes regardless of rescue medication use.		First 24 hours after surgery.	No