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NCT00600990 Clinical Trial

Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:
Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00600990
Other study ID # NKO101287
Secondary ID
Status Completed
Phase Phase 2
First received January 15, 2008
Last updated January 19, 2017
Start date December 2004
Est. completion date July 2006

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

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).

Description:

A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous 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 PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk

Recruitment information / eligibility
Status Completed
Enrollment 624
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- known risk factors for PONV.

- Undergoing gynecological or gallbladder surgery.

Study Design

Related Conditions & MeSH terms

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

Intervention

Drug:
• GW597599

Locations
Country Name City State
Australia GSK Investigational Site Carlton Victoria
Australia GSK Investigational Site Melbourne Victoria
Australia GSK Investigational Site Ringwood East Victoria
Australia GSK Investigational Site St Leonards New South Wales
Australia GSK Investigational Site Subiaco Western Australia
Australia GSK Investigational Site Westmead New South Wales
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Leuven
Canada GSK Investigational Site Chandler Quebec
Canada GSK Investigational Site Charlottetown Prince Edward Island
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site Kingston Ontario
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Regina Saskatchewan
Canada GSK Investigational Site Sudbury Ontario
Canada GSK Investigational Site Victoria British Columbia
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago Región Metro De Santiago
Czech Republic GSK Investigational Site Brno
Czech Republic GSK Investigational Site Jihlava
Czech Republic GSK Investigational Site Olomouc
Czech Republic GSK Investigational Site Ostrava - Poruba
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Kuopio
Netherlands GSK Investigational Site Roosendaal
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Rotterdam
Poland GSK Investigational Site Poznan
Poland GSK Investigational Site Warszawa
Poland GSK Investigational Site Warszawa
South Africa GSK Investigational Site Arcadia, Pretoria
South Africa GSK Investigational Site Bloemfontein
Turkey GSK Investigational Site Istanbul
Turkey GSK Investigational Site Istanbul
United Kingdom GSK Investigational Site Chelmsford Essex
United Kingdom GSK Investigational Site Northampton Northamptonshire
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Boca Raton Florida
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Glendale California
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Laguna Hills California
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site New York New York
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Pasadena California
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Chile,  Czech Republic,  Finland,  Netherlands,  Poland,  South Africa,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Secondary The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
See also
  Status Clinical Trial Phase
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Completed NCT03139383 - Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery N/A
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