Last updated: 11/04/2018 09:44:34
A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: intravenous ondansetron
Enrollment:
701
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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;113(1):74-82.
Medical condition
Postoperative Nausea and Vomiting
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
October 2004 to August 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 55 years
Accepts healthy volunteers
No
- Females age 18-55
- Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal
- Pregnant or breastfeeding
- Post-menopausal
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56073
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 92653
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Arcadia, California, United States, 91007
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91109
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 3C6
Status
Study Complete
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10025
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78240
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Hutchinson, Kansas, United States, 67502
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 8903
Status
Study Complete
Location
GSK Investigational Site
Alpharetta, Georgia, United States, 30005
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Glendale, California, United States, 91206
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
Status
Study Complete
Location
GSK Investigational Site
Duarte, California, United States, 91010
Status
Study Complete
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-08-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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