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

NCT00539721 | Completed Phase 2

• 1 other identifier: P04937
• Study Type: interventional
• Target: 619
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• No emetic episodes regardless of rescue medication use.

  First 24 hours after surgery.

Study Arms (6)

Rolapitant Dose 1

EXPERIMENTAL

Drug: Rolapitant Dose 1

Rolapitant Dose 2

EXPERIMENTAL

Drug: Rolapitant Dose 2

Rolapitant Dose 3

EXPERIMENTAL

Drug: Rolapitant Dose 3

Rolapitant Dose 4

EXPERIMENTAL

Drug: Rolapitant Dose 4

Ondansetron

ACTIVE COMPARATOR

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rolapitant Dose 1 DRUG

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

Rolapitant Dose 1

Rolapitant Dose 2 DRUG

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

Rolapitant Dose 2

Rolapitant Dose 3 DRUG

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

Rolapitant Dose 3

Rolapitant Dose 4 DRUG

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

Rolapitant Dose 4

Ondansetron DRUG

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

Ondansetron

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 1, 2013

Record last verified: 2013-10