Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
1 other identifier
interventional
482
11 countries
58
Brief Summary
This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
Shorter than P25 for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedOctober 26, 2016
October 1, 2016
4 months
May 12, 2006
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of vomiting and retching
after surgery
Secondary Outcomes (1)
Rates of nausea. Blood test results.
after surgery
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- History of PONV and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain types of abdominal, breast or shoulder surgeries.
You may not qualify if:
- Pregnant or breastfeeding.
- Taking certain medications.
- Have certain pre-existing medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (58)
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Sheffield, Alabama, 35660, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Naples, Florida, 34108, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
Anderson, Indiana, 46011, United States
GSK Investigational Site
Grand Rapids, Michigan, 49503, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
New Brunswick, New Jersey, 08901, United States
GSK Investigational Site
New Brunswick, New Jersey, 8903, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
GSK Investigational Site
Altoona, Pennsylvania, 16602, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
San Antonio, Texas, 78240, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Edmonton, Alberta, T5H 3V9, Canada
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6, Canada
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 8T5, Canada
GSK Investigational Site
Québec, Quebec, G1L 3L5, Canada
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5, Canada
GSK Investigational Site
Bordeaux, 33000, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Caen, 14050, France
GSK Investigational Site
Lyon, 69008, France
GSK Investigational Site
Lyon, 69288, France
GSK Investigational Site
Paris, 75970, France
GSK Investigational Site
Rennes, 35000, France
GSK Investigational Site
Riom, 63204, France
GSK Investigational Site
Strasbourg, 67098 cedex, France
GSK Investigational Site
Marburg, Hesse, 35043, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56073, Germany
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
GSK Investigational Site
Győr, 9023, Hungary
GSK Investigational Site
Miskolc, 3529, Hungary
GSK Investigational Site
Szentes, 6600, Hungary
GSK Investigational Site
Székesfehérvár, 8001, Hungary
GSK Investigational Site
Dublin, Ireland
GSK Investigational Site
Galway, Ireland
GSK Investigational Site
Karachi, 74800, Pakistan
GSK Investigational Site
Manila, 1003, Philippines
GSK Investigational Site
Santa Cruz, Manila, 1003, Philippines
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN, United Kingdom
GSK Investigational Site
Livingston, West Lothian, EH54 6PP, United Kingdom
GSK Investigational Site
Liverpool, L8 7SS, United Kingdom
Related Publications (1)
Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.
PMID: 21339433BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 16, 2006
Study Start
March 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
October 26, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.