A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
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
1 other identifier
interventional
701
6 countries
58
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2004
Shorter than P25 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 13, 2005
CompletedFirst Posted
Study publicly available on registry
April 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 20, 2017
January 1, 2017
10 months
April 13, 2005
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
The extent of nausea experienced by subjects.
Interventions
Eligibility Criteria
You may qualify if:
- Females age 18-55
- Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal
You may not qualify if:
- Pregnant or breastfeeding
- Post-menopausal
- Not undergoing general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (58)
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Arcadia, California, 91007, United States
GSK Investigational Site
Duarte, California, 91010, United States
GSK Investigational Site
Glendale, California, 91206, United States
GSK Investigational Site
Laguna Hills, California, 92653, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
Pasadena, California, 91109, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Stanford, California, 94305, United States
GSK Investigational Site
Naples, Florida, 34108, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
Alpharetta, Georgia, 30005, United States
GSK Investigational Site
Hutchinson, Kansas, 67502, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70806, United States
GSK Investigational Site
Baltimore, Maryland, 21229-5299, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
New Brunswick, New Jersey, 8903, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
San Antonio, Texas, 78240, United States
GSK Investigational Site
Winchester, Virginia, 22601, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Braasschaat, 2930, Belgium
GSK Investigational Site
Brussels, 1020, Belgium
GSK Investigational Site
Calgary, Alberta, T2N 2T9, Canada
GSK Investigational Site
Edmonton, Alberta, T5H 3V9, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 3C6, Canada
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
GSK Investigational Site
London, Ontario, N6A 4G5, Canada
GSK Investigational Site
London, Ontario, N6A 4V2, Canada
GSK Investigational Site
Toronto, Ontario, M5T 2S8, Canada
GSK Investigational Site
Montreal, Quebec, H3A 1A1, Canada
GSK Investigational Site
Québec, Quebec, G1L 3L5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
GSK Investigational Site
Ste-Foy, Quebec, G1V 4G2, Canada
GSK Investigational Site
Marburg, Hesse, 35043, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56073, Germany
GSK Investigational Site
Győr, 9023, Hungary
GSK Investigational Site
Kistarcsa, 2143, Hungary
GSK Investigational Site
Miskolc, 3529, Hungary
GSK Investigational Site
Székesfehérvár, 8001, Hungary
GSK Investigational Site
Cadiz, 11009, Spain
GSK Investigational Site
Cartagena, 30203, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
Related 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.
PMID: 20526194BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2005
First Posted
April 14, 2005
Study Start
October 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 20, 2017
Record last verified: 2017-01