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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

Page last updated: June 20, 2008

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