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

NCT ID: NCT00108095

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

701 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting Nausea and Vomiting, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intravenous ondansetron

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Montgomery, Alabama, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Arcadia, California, United States

Site Status

GSK Investigational Site

Duarte, California, United States

Site Status

GSK Investigational Site

Glendale, California, United States

Site Status

GSK Investigational Site

Laguna Hills, California, United States

Site Status

GSK Investigational Site

Loma Linda, California, United States

Site Status

GSK Investigational Site

Pasadena, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Stanford, California, United States

Site Status

GSK Investigational Site

Naples, Florida, United States

Site Status

GSK Investigational Site

Pensacola, Florida, United States

Site Status

GSK Investigational Site

Alpharetta, Georgia, United States

Site Status

GSK Investigational Site

Hutchinson, Kansas, United States

Site Status

GSK Investigational Site

Kansas City, Kansas, United States

Site Status

GSK Investigational Site

Baton Rouge, Louisiana, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Jackson, Mississippi, United States

Site Status

GSK Investigational Site

New Brunswick, New Jersey, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Winchester, Virginia, United States

Site Status

GSK Investigational Site

Wenatchee, Washington, United States

Site Status

GSK Investigational Site

Aalst, , Belgium

Site Status

GSK Investigational Site

Braasschaat, , Belgium

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Calgary, Alberta, Canada

Site Status

GSK Investigational Site

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Vancouver, British Columbia, Canada

Site Status

GSK Investigational Site

Vancouver, British Columbia, Canada

Site Status

GSK Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

GSK Investigational Site

Halifax, Nova Scotia, Canada

Site Status

GSK Investigational Site

Hamilton, Ontario, Canada

Site Status

GSK Investigational Site

London, Ontario, Canada

Site Status

GSK Investigational Site

London, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Québec, Quebec, Canada

Site Status

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

GSK Investigational Site

Ste-Foy, Quebec, Canada

Site Status

GSK Investigational Site

Marburg, Hesse, Germany

Site Status

GSK Investigational Site

Aachen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Győr, , Hungary

Site Status

GSK Investigational Site

Kistarcsa, , Hungary

Site Status

GSK Investigational Site

Miskolc, , Hungary

Site Status

GSK Investigational Site

Székesfehérvár, , Hungary

Site Status

GSK Investigational Site

Cadiz, , Spain

Site Status

GSK Investigational Site

Cartagena, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Santiago de Compostela, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada Germany Hungary Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20526194 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NKT102260

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.