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NCT00108095 Clinical Trial

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00108095
Other study ID # NKT102260
Secondary ID
Status Completed
Phase Phase 2
First received April 13, 2005
Last updated January 19, 2017
Start date October 2004
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

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Description:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) 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 701
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:

- Females age 18-55

- Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

- Pregnant or breastfeeding

- Post-menopausal

- Not undergoing general anesthesia

Study Design

Related Conditions & MeSH terms

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

Intervention

Drug:
• intravenous ondansetron

Locations
Country Name City State
Belgium GSK Investigational Site Aalst
Belgium GSK Investigational Site Braasschaat
Belgium GSK Investigational Site Bruxelles
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Saint John's Newfoundland and Labrador
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Ste-Foy Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Vancouver British Columbia
Canada GSK Investigational Site Vancouver British Columbia
Germany GSK Investigational Site Aachen Nordrhein-Westfalen
Germany GSK Investigational Site Koblenz Rheinland-Pfalz
Germany GSK Investigational Site Marburg Hessen
Hungary GSK Investigational Site Gyor
Hungary GSK Investigational Site Kistarcsa
Hungary GSK Investigational Site Miskolc
Hungary GSK Investigational Site Székesfehérvár
Spain GSK Investigational Site Cadiz
Spain GSK Investigational Site Cartagena
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Santiago de Compostela
United States GSK Investigational Site Alpharetta Georgia
United States GSK Investigational Site Arcadia California
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Baton Rouge Louisiana
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Duarte California
United States GSK Investigational Site Glendale California
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Hutchinson Kansas
United States GSK Investigational Site Jackson Mississippi
United States GSK Investigational Site Kansas City Kansas
United States GSK Investigational Site Laguna Hills California
United States GSK Investigational Site Loma Linda California
United States GSK Investigational Site Montgomery Alabama
United States GSK Investigational Site Naples Florida
United States GSK Investigational Site New Brunswick New Jersey
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Pasadena California
United States GSK Investigational Site Pensacola Florida
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Diego California
United States GSK Investigational Site Stanford California
United States GSK Investigational Site Wenatchee Washington
United States GSK Investigational Site Winchester Virginia
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Hungary,  Spain, 

References & Publications (1)

Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010 Jul;113(1):74-82. doi: 10.1097/ALN.0b013e3181d7b13a. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia
Secondary Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
Secondary The extent of nausea experienced by subjects.
See also
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Completed NCT04043247 - Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting N/A
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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