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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00539721 |
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 II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| 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 |
|---|---|
| Rolapitant Dose 1: Experimental |
Drug: Rolapitant Dose 1
Rolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
|
| Rolapitant Dose 2: Experimental |
Drug: Rolapitant Dose 2
Rolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
|
| Rolapitant Dose 3: Experimental |
Drug: Rolapitant Dose 3
Rolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
|
| Rolapitant Dose 4: Experimental |
Drug: Rolapitant Dose 4
200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
|
| Ondansetron: Active Comparator |
Drug: Ondansetron
Ondansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
|
| Placebo: Placebo Comparator |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04937 |
| Study First Received: | October 2, 2007 |
| Last Updated: | October 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00539721 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Nausea Vomiting |
|
Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Antiemetics Signs and Symptoms Serotonin Antagonists Pathologic Processes Therapeutic Uses Antipruritics Nausea Ondansetron |
Dermatologic Agents Postoperative Nausea and Vomiting Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Serotonin Agents Postoperative Complications Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |