A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: Rolapitant Dose 1 (Drug); Rolapitant Dose 2 (Drug); Rolapitant Dose 3 (Drug); Rolapitant Dose 4 (Drug); Ondansetron (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Schering-Plough Official(s) and/or principal investigator(s):
E. D. Kramer, MD, Study Director, Affiliation: Schering-Plough
Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: No emetic episodes regardless of rescue medication use.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 52, Montreal H1T 2M4, Canada; Recruiting
Investigational Site 54, Toronto M5T 2S8, Canada; Recruiting
Investigational Site 55, Edmonton T6G 2G3, Canada; Recruiting
Investigational Site 51, Montreal H4J 1C5, Canada; Recruiting
Investigational Site 26, Sheffield, Alabama 35660, United States; Recruiting
Investigational Site 49, Florence, Alabama 35630, United States; Recruiting
Investigational Site 40, Tucson, Arizona 85724, United States; Recruiting
Investigational Site 10, Pasadena, California 91109, United States; Recruiting
Investigational Site 33, Arcadia, California 91007, United States; Recruiting
Investigational Site 37, Glendale, California 91206, United States; Recruiting
Investigational Site 8, San Francisco, California 94143-0648, United States; Recruiting
Investigational Site 18, Denver, Colorado 80262, United States; Recruiting
Investigational Site 6, Miami, Florida 33136, United States; Recruiting
Investigational Site 30, Miami, Florida 33146, United States; Recruiting
Investigational Site 47, Atlanta, Georgia 30306, United States; Recruiting
Investigational Site 22, Kansas City, Kansas 66160, United States; Recruiting
Investigational Site 7, Edgewood, Kentucky 41017, United States; Recruiting
Investigational Site 31, Boston, Massachusetts 02115, United States; Recruiting
Investigational Site 14, Camden, New Jersey 08103, United States; Recruiting
Investigational Site 15, Albany, New York 12208, United States; Recruiting
Investigational Site 16, Durham, North Carolina 27710, United States; Recruiting
Investigational Site 32, Winston-Salem, North Carolina 27157, United States; Recruiting
Investigational Site 9, Cleveland, Ohio 44111, United States; Recruiting
Investigational Site 11, Bartlesville, Oklahoma 74006, United States; Recruiting
Investigational Site 44, Hershey, Pennsylvania 17033, United States; Recruiting
Investigational site 50, Pittsburgh, Pennsylvania 15213-3180, United States; Recruiting
Investigational Site 34, Philadelphia, Pennsylvania 19107, United States; Recruiting
Investigational Site 17, Charleston, South Carolina 29425, United States; Recruiting
Investigational Site 28, Houston, Texas 77054, United States; Recruiting
Investigational Site 29, Houston, Texas 77024, United States; Recruiting
Additional Information
Starting date: October 2007
Ending date: May 2008
Last updated: May 28, 2008
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