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NCT00274690 Clinical Trial

Post-Operative Nausea And Vomiting Study In Female Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:
A Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing With GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered With a Single Intravenous Dose of Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects With Known Risk Factors for Post-operative Nausea and Vomiting Who Are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated With an Increased Emetogenic Risk

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00274690
Other study ID # NKT102245
Secondary ID
Status Completed
Phase Phase 2
First received January 9, 2006
Last updated January 19, 2017
Start date February 2005
Est. completion date August 2005

Study information
Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.

Description:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk

Recruitment information / eligibility
Status Completed
Enrollment 435
Est. completion date August 2005
Est. primary completion date August 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Known, specified risk factors for PONV (post operative nausea and vomiting)

- Undergoing gynecologic or gallbladder surgery.

Exclusion Criteria:

- pregnant or breastfeeding

- post-menopausal

Study Design

Related Conditions & MeSH terms

  • Nausea
  • Nausea and Vomiting, Postoperative
  • Postoperative Nausea and Vomiting
  • Vomiting

Intervention

Drug:
• GW679769

Locations
Country Name City State
Denmark GSK Investigational Site Glostrup
Denmark GSK Investigational Site Koebenhavn
Denmark GSK Investigational Site Viborg
Hong Kong GSK Investigational Site Lai Chi kok
Hong Kong GSK Investigational Site Pokfulam
Hong Kong GSK Investigational Site Shamshuipo, Kowloon
Hong Kong GSK Investigational Site Shatin, New Territories
Hong Kong GSK Investigational Site Tuen Mun
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Szentes
Israel GSK Investigational Site Kfar Saba
Israel GSK Investigational Site Tel-Hashomer
Norway GSK Investigational Site Gjettum
Norway GSK Investigational Site Oslo
Norway GSK Investigational Site Skien
Philippines GSK Investigational Site Manila
Philippines GSK Investigational Site Manila
Slovenia GSK Investigational Site Ljubljana
Slovenia GSK Investigational Site Novo Mesto
Slovenia GSK Investigational Site Slovenj Gradec
Spain GSK Investigational Site Badalona(Barcelona)
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Pamplona
Thailand GSK Investigational Site Bangkok
Thailand GSK Investigational Site Bangkok
United Kingdom GSK Investigational Site Edinburgh Midlothian
United Kingdom GSK Investigational Site Glasgow Lanarkshire
United Kingdom GSK Investigational Site Glasgow Lanarkshire
United Kingdom GSK Investigational Site Glasgow Lanarkshire
United Kingdom GSK Investigational Site Hull
United Kingdom GSK Investigational Site Livingston West Lothian
United States GSK Investigational Site Camden New Jersey
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Grand Rapids Michigan
United States GSK Investigational Site Melbourne Florida
United States GSK Investigational Site Royal Oak Michigan
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Denmark,  Hong Kong,  Hungary,  Israel,  Norway,  Philippines,  Slovenia,  Spain,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia. 72 Hours
Secondary The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia. 120 Hours
See also
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Recruiting NCT04069806 - Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section N/A
Completed NCT04043247 - Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting N/A
Terminated NCT01975727 - Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting Phase 2
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT00090155 - 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Phase 3
Recruiting NCT05375721 - Prevention of PONV With Traditional Chinese Medicine N/A
Completed NCT02480088 - Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism Phase 4
Recruiting NCT06137027 - Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting Early Phase 1
Not yet recruiting NCT05529004 - A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy Phase 2
Completed NCT02944942 - Risk Factors for Postoperative Nausea/Vomiting N/A
Recruiting NCT02571153 - Low Doses of Ketamine and Postoperative Quality of Recovery Phase 4
Completed NCT02449291 - Study of APD421 as PONV Treatment (no Prior Prophylaxis) Phase 3
Completed NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
Recruiting NCT01442012 - Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery N/A
Completed NCT01478165 - Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A
Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4