Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for 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: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: casopitant

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • GSK Investigational Site
  • Brasschaat, Belgium, 2930
    • GSK Investigational Site
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 1X5
      • GSK Investigational Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 4G2
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • GSK Investigational Site
• Czech Republic
  • Brno, Czech Republic, 625 00
    • GSK Investigational Site
  • Jihlava, Czech Republic, 586 01
    • GSK Investigational Site
  • Olomouc, Czech Republic, 775 20
    • GSK Investigational Site
  • Pardubice, Czech Republic, 532 03
    • GSK Investigational Site
  • Praha 2, Czech Republic, 128 51
    • GSK Investigational Site
  • Praha 5, Czech Republic, 150 08
    • GSK Investigational Site
• Germany
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79110
      • GSK Investigational Site
  • Hessen
    • Marburg, Hessen, Germany, 35043
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
      • GSK Investigational Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • GSK Investigational Site
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • GSK Investigational Site
    • Wismar, Mecklenburg-Vorpommern, Germany, 23966
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
      • GSK Investigational Site
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • GSK Investigational Site
• Hong Kong
  • Kwun Tong, Hong Kong
    • GSK Investigational Site
  • Pokfulam, Hong Kong
    • GSK Investigational Site
  • Shatin, New Territories, Hong Kong
    • GSK Investigational Site
  • Sheung Shui, New Territories, Hong Kong
    • GSK Investigational Site
• Pakistan
  • Lahore, Pakistan
    • GSK Investigational Site
• Philippines
  • Manila, Philippines, 1000
    • GSK Investigational Site
  • Quezon, City, Philippines, 1104
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 101000
    • GSK Investigational Site
  • Moscow, Russian Federation, 111538
    • GSK Investigational Site
  • Moscow, Russian Federation, 117152
    • GSK Investigational Site
  • Perm, Russian Federation, 614107
    • GSK Investigational Site
  • St. Petersburgh, Russian Federation, 192242
    • GSK Investigational Site
• Spain
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • La Coruña, Spain, 15006
    • GSK Investigational Site
  • Mataro, Spain, 08034
    • GSK Investigational Site
  • Pamplona, Spain, 31008
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand
    • GSK Investigational Site
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • GSK Investigational Site
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
    • Montgomery, Alabama, United States, 36106
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Arcadia, California, United States, 91007
      • GSK Investigational Site
    • Glendale, California, United States, 91206
      • GSK Investigational Site
    • Laguna Hills, California, United States, 92653
      • GSK Investigational Site
    • Pasadena, California, United States, 91105
      • GSK Investigational Site
  • Florida
    • Boca Raton, Florida, United States, 33067
      • GSK Investigational Site
    • Melbourne, Florida, United States, 32901
      • GSK Investigational Site
    • Miami, Florida, United States, 33143
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • GSK Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21229-5299
      • GSK Investigational Site
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • GSK Investigational Site
  • New York
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • New Hyde Park, New York, United States, 11040
      • GSK Investigational Site
    • New York, New York, United States, 10038
      • GSK Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45208
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • GSK Investigational Site
    • Winchester, Virginia, United States, 22601
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98195
      • 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 (postoperative nausea and vomiting) and/or motion sickness.
• Have not smoked for the last 6 months.
• Having certain abdominal, breast, thyroid or shoulder surgery.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who achieved a complete response	Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a "0-10 Likert scale"	Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a Likert scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. The Likert scale used a range of 0-10, where 0 = no nausea and 10 = nausea as bad as it could be.	Up to 48 hours
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol	Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a categorical scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. In the categorical scale, each participant asked to rate the severity of nausea as, none: no nausea, mild: queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit (but not vomiting), that has a significant negative effect on daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others), severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities.	Up to 48 hours
Number of participants with first emetic event		Up to 48 hours
Number of participants with first antiemetic rescue medication		Up to 48 hours
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary		Up to 48 hours
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary		Up to 48 hours
Number of participants with chemistry data outside the reference range		Up to 48 hours
Number of participants with hematology data outside the reference range		Up to 48 hours
Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command)		Up to 24 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Refer to the general AE/SAE module for a list of AEs and SAEs.	Up to Days 6-14 visit

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

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: June 2, 2006
• First Submitted That Met QC Criteria: June 2, 2006
• First Posted (Estimate): June 6, 2006

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: PONV; postoperative nausea and vomiting; NK-1; antiemetics; casopitant mesylate; ondansetron hydrochloride; 5HT3; ZOFRAN
• 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: NKT102552

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. Dataset Specification
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: NKT102552
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register