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

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.

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: GW679769 (casopitant)

• Study Type: Interventional
• Enrollment (Actual): 482
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1L 3L5
    • GSK Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • GSK Investigational Site
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
      • GSK Investigational Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • GSK Investigational Site
• France
  • Bordeaux, France, 33000
    • GSK Investigational Site
  • Caen Cedex, France, 14050
    • GSK Investigational Site
  • Caen Cedex, France, 14033
    • GSK Investigational Site
  • Lyon, France, 69008
    • GSK Investigational Site
  • Lyon Cedex 02, France, 69288
    • GSK Investigational Site
  • Paris Cedex 20, France, 75970
    • GSK Investigational Site
  • Rennes, France, 35000
    • GSK Investigational Site
  • Riom, France, 63204
    • GSK Investigational Site
  • Strasbourg, France, 67098 cedex
    • GSK Investigational Site
• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35043
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56073
      • GSK Investigational Site
• Hong Kong
  • Pokfulam, Hong Kong
    • GSK Investigational Site
  • Shatin, New Territories, Hong Kong
    • GSK Investigational Site
• Hungary
  • Győr, Hungary, 9023
    • GSK Investigational Site
  • Miskolc, Hungary, 3529
    • GSK Investigational Site
  • Szentes, Hungary, 6600
    • GSK Investigational Site
  • Székesfehérvár, Hungary, 8001
    • GSK Investigational Site
• Ireland
  • Dublin, Ireland
    • GSK Investigational Site
  • Galway, Ireland
    • GSK Investigational Site
• Pakistan
  • Karachi, Pakistan, 74800
    • GSK Investigational Site
• Philippines
  • Manila, Philippines, 1003
    • GSK Investigational Site
  • Sta. Cruz, Manila, Philippines, 1003
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10700
    • GSK Investigational Site
• United Kingdom
  • Liverpool, United Kingdom, L8 7SS
    • GSK Investigational Site
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G12 0YN
      • GSK Investigational Site
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 6PP
      • GSK Investigational Site
• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
      • GSK Investigational Site
    • Sheffield, Alabama, United States, 35660
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • GSK Investigational Site
  • California
    • Los Angeles, California, United States, 90033
      • GSK Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Melbourne, Florida, United States, 32901
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Naples, Florida, United States, 34108
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32504
      • GSK Investigational Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • GSK Investigational Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • GSK Investigational Site
    • New Brunswick, New Jersey, United States, 8903
      • GSK Investigational Site
  • New York
    • Bronx, New York, United States, 10467
      • GSK Investigational Site
    • New York, New York, United States, 10025
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19102
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78240
      • GSK Investigational Site
  • Washington
    • Spokane, Washington, United States, 99204
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• History of PONV and/or motion sickness.
• Have not smoked for the last 6 months.
• Having certain types of abdominal, breast or shoulder surgeries.

Exclusion criteria:

• Pregnant or breastfeeding.
• Taking certain medications.
• Have certain pre-existing medical conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: GW679769 (casopitant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of vomiting and retching	after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of nausea. Blood test results.	after surgery

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: May 12, 2006
• First Submitted That Met QC Criteria: May 12, 2006
• First Posted (Estimate): May 16, 2006

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Casopitant
• Other Study ID Numbers: NKT102553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: NKT102553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register