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
• 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
• 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

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.