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

Primary Purpose

Nausea and Vomiting, Postoperative, Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
casopitant
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea and Vomiting, Postoperative focused on measuring NK-1, antiemetics, casopitant mesylate, postoperative nausea and vomiting, ondansetron hydrochloride, 5HT3, ZOFRAN, PONV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of participants with first emetic event
Number of participants with first antiemetic rescue medication
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
Number of participants with chemistry data outside the reference range
Number of participants with hematology data outside the reference range
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)
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.

Full Information

First Posted
June 2, 2006
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00334152
Brief Title
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative, Postoperative Nausea and Vomiting
Keywords
NK-1, antiemetics, casopitant mesylate, postoperative nausea and vomiting, ondansetron hydrochloride, 5HT3, ZOFRAN, PONV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
casopitant
Primary Outcome Measure Information:
Title
Number of participants who achieved a complete response
Description
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.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
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"
Description
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.
Time Frame
Up to 48 hours
Title
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
Description
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.
Time Frame
Up to 48 hours
Title
Number of participants with first emetic event
Time Frame
Up to 48 hours
Title
Number of participants with first antiemetic rescue medication
Time Frame
Up to 48 hours
Title
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
Time Frame
Up to 48 hours
Title
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
Time Frame
Up to 48 hours
Title
Number of participants with chemistry data outside the reference range
Time Frame
Up to 48 hours
Title
Number of participants with hematology data outside the reference range
Time Frame
Up to 48 hours
Title
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)
Time Frame
Up to 24 hours
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Description
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.
Time Frame
Up to Days 6-14 visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
GSK Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
GSK Investigational Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
GSK Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
GSK Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
GSK Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
GSK Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5299
Country
United States
Facility Name
GSK Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
GSK Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
GSK Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45208
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
GSK Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
GSK Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
GSK Investigational Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Jihlava
ZIP/Postal Code
586 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 51
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 08
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79110
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
GSK Investigational Site
City
Neubrandenburg
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17036
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18059
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
GSK Investigational Site
City
Wismar
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
23966
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
GSK Investigational Site
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
GSK Investigational Site
City
Kwun Tong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Sheung Shui, New Territories
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Lahore
Country
Pakistan
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Quezon, City
ZIP/Postal Code
1104
Country
Philippines
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
111538
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Perm
ZIP/Postal Code
614107
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburgh
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
GSK Investigational Site
City
Mataro
ZIP/Postal Code
08034
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102552
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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

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