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

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ClinicalTrials.gov Identifier: NCT00539721
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Rolapitant Dose 1 Drug: Rolapitant Dose 2 Drug: Rolapitant Dose 3 Drug: Rolapitant Dose 4 Drug: Ondansetron Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 619 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rolapitant
U.S. FDA Resources

Arm Intervention/treatment
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
Placebo Comparator: Placebo Drug: Placebo
Rolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1



Primary Outcome Measures :
  1. No emetic episodes regardless of rescue medication use. [ Time Frame: First 24 hours after surgery. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00539721     History of Changes
Other Study ID Numbers: P04937
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Merck Sharp & Dohme Corp.:
Nausea
Vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Neurokinin-1 Receptor Antagonists