Back to results

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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Rolapitant Dose 1

Rolapitant Dose 2

Rolapitant Dose 3

Rolapitant Dose 4

Ondansetron

Placebo

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Rolapitant Dose 1

Rolapitant Dose 2

Rolapitant Dose 3

Rolapitant Dose 4

Ondansetron

Placebo

Arm Description

Outcomes

Primary Outcome Measures

No emetic episodes regardless of rescue medication use.

Secondary Outcome Measures

Full Information

NCT ID

NCT00539721

First Posted

October 2, 2007

Last Updated

October 8, 2013

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00539721

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

Nausea, Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

619 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rolapitant Dose 1

Arm Type

Experimental

Arm Title

Rolapitant Dose 2

Arm Type

Experimental

Arm Title

Rolapitant Dose 3

Arm Type

Experimental

Arm Title

Rolapitant Dose 4

Arm Type

Experimental

Arm Title

Ondansetron

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Rolapitant Dose 1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rolapitant Dose 2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rolapitant Dose 3

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rolapitant Dose 4

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

No emetic episodes regardless of rescue medication use.

Time Frame

First 24 hours after surgery.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs