A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: intravenous ondansetron (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia

Secondary outcome:

Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia

The extent of nausea experienced by subjects.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

Inclusion criteria:

- Females age 18-55

- Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

- Pregnant or breastfeeding

- Post-menopausal

- Not undergoing general anesthesia

GSK Clinical Trials Call Centre, Aalst 9300, Belgium

GSK Clinical Trials Call Centre, Brugge 8000, Belgium

GSK Clinical Trials Call Centre, Braasschaat 2930, Belgium

GSK Clinical Trials Call Centre, Brussel 1020, Belgium

GSK Clinical Trials Call Centre, Rostock 18059, Germany

GSK Clinical Trials Call Centre, Neubrandenburg 17036, Germany

GSK Clinical Trials Call Centre, Kiel 24105, Germany

GSK Clinical Trials Call Centre, Schwerin 19055, Germany

GSK Clinical Trials Call Centre, Wismar 23966, Germany

GSK Clinical Trials Call Centre, Freiburg 79110, Germany

GSK Clinical Trials Call Centre, Koblenz 56073, Germany

GSK Clinical Trials Call Centre, Berlin 13125, Germany

GSK Clinical Trials Call Centre, Szekesfehervar 8001, Hungary

GSK Clinical Trials Call Centre, Gyor 9022, Hungary

GSK Clinical Trials Call Centre, Miskolc 3529, Hungary

GSK Clinical Trials Call Centre, Kistarcsa 2143, Hungary

GSK Clinical Trials Call Centre, Budapest 1134, Hungary

GSK Clinical Trials Call Centre, A Coruna 15706, Spain

GSK Clinical Trials Call Centre, Murcia 30203, Spain

GSK Clinical Trials Call Centre, Madrid 28034, Spain

GSK Clinical Trials Call Center, Montgomery, Alabama 36106, United States

GSK Clinical Trials Call Center, Montgomery, Alabama 36106, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85032, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85032, United States

GSK Clinical Trials Call Center, Tucson, Arizona 85711, United States

GSK Clinical Trials Call Center, Loma Linda, California 92350, United States

GSK Clinical Trials Call Center, Stanford, California 94305, United States

GSK Clinical Trials Call Center, Duarte, California 91010, United States

GSK Clinical Trials Call Center, Pasadena, California 91109, United States

GSK Clinical Trials Call Center, Arcadia, California 91007, United States

GSK Clinical Trials Call Center, Glendale, California 91206, United States

GSK Clinical Trials Call Center, Laguna Hills, California 92653, United States

GSK Clinical Trials Call Center, Valley Center, California 92087, United States

GSK Clinical Trials Call Center, Naples, Florida 34119, United States

GSK Clinical Trials Call Center, Miami Beach, Florida 33140, United States

GSK Clinical Trials Call Center, Pensacola, Florida 32504, United States

GSK Clinical Trials Call Center, Marietta, Georgia 30060, United States

GSK Clinical Trials Call Center, Alpharetta, Georgia 30005, United States

GSK Clinical Trials Call Centre, Marburg, Hessen 35043, Germany

GSK Clinical Trials Call Center, Maywood, Illinois 60153, United States

GSK Clinical Trials Call Center, Hutchinson, Kansas 67502, United States

GSK Clinical Trials Call Center, Kansas City, Kansas 66160, United States

GSK Clinical Trials Call Center, Baton Rouge, Louisiana 70806, United States

GSK Clinical Trials Call Center, Baltimore, Maryland 21229, United States

GSK Clinical Trials Call Center, Jackson, Missouri 39202, United States

GSK Clinical Trials Call Center, Washington, Missouri 63090, United States

GSK Clinical Trials Call Center, New Brunswick, New Jersey 08903, United States

GSK Clinical Trials Call Center, Hackensack, New Jersey 07601, United States

GSK Clinical Trials Call Center, Syracuse, New York 13210, United States

GSK Clinical Trials Call Center, New York, New York 10016, United States

GSK Clinical Trials Call Center, Stoney Brook, New York 11794, United States

GSK Clinical Trials Call Center, New York, New York 10025, United States

GSK Clinical Trials Call Centre, Aachen, Nordrhein-Westfalen 52074, Germany

GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15224, United States

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15213, United States

Study Site, Ludwigshafen, Rheinland-Pfailz 67063, Germany

GSK Clinical Trials Call Centre, Homburg/Saar, Saarland 66421, Germany

GSK Clinical Trials Call Center, Charleston, South Carolina 29425, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78209, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Houston, Texas 77054, United States

GSK Clinical Trials Call Center, Houston, Texas 77024, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78240, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Winchester, Virginia 22601, United States

GSK Clinical Trials Call Center, Wenatchee, Washington 98801, United States

Starting date: October 2004
Last updated: October 5, 2006