A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00539721
First received: October 2, 2007
Last updated: October 16, 2009
Last verified: October 2009
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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) |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- No emetic episodes regardless of rescue medication use. [ Time Frame: First 24 hours after surgery. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00539721 History of Changes |
| Other Study ID Numbers: | P04937 |
| Study First Received: | October 2, 2007 |
| Last Updated: | October 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
Nausea Vomiting |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses 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 |
ClinicalTrials.gov processed this record on June 18, 2013