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

Purpose

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

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: intravenous ondansetron	Phase II

MedlinePlus related topics:

Anesthesia Nausea and Vomiting

ChemIDplus related topics:

Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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, 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	665
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108095

Show 69 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	NKT102260
First Received:	April 13, 2005
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00108095
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

nausea

vomiting

emesis

PONV

post operative nausea and vomiting

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Nausea and Vomiting

Vomiting

Postoperative Complications

Signs and Symptoms, Digestive

Nausea

Ondansetron

Serotonin

Substance P

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Gastrointestinal Agents

Central Nervous System Depressants

Antiemetics

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Pathologic Processes

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Antipruritics

Anti-Anxiety Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00108095