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

Tracking Information
First Received Date ^ICMJE	October 2, 2007
Last Updated Date	October 16, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	No emetic episodes regardless of rescue medication use. [ Time Frame: First 24 hours after surgery. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 3, 2007)	To assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting. [ Time Frame: First 24 hours after surgery. ]
Change History	Complete list of historical versions of study NCT00539721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: October 3, 2007)	To compare the effects of rolapitant and placebo in the prevention of nausea and vomiting and on the use of rescue medication. [ Time Frame: Five days after surgery (efficacy); between 30 and 60 days after surgery (safety). ] To evaluate the safety and tolerability of rolapitant in the prevention of postoperative nausea and vomiting. [ Time Frame: Five days after surgery (efficacy); between 30 and 60 days after surgery (safety). ]

Descriptive Information
Brief Title ^ICMJE	A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
Official Title ^ICMJE	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)
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Postoperative Nausea and Vomiting
Intervention ^ICMJE	Drug: Rolapitant Dose 1 Drug: Rolapitant Dose 2 Drug: Rolapitant Dose 3 Drug: Rolapitant Dose 4 Drug: Ondansetron Drug: Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	600
Completion Date	July 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00539721
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P04937
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP