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Post-Operative Nausea And Vomiting Study In Female Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00274690
First received: January 9, 2006
Last updated: May 31, 2012
Last verified: November 2011
History of Changes
  Purpose

The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
 Drug: GW679769
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia. [ Time Frame: 72 Hours ]

Secondary Outcome Measures:
  • The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia. [ Time Frame: 120 Hours ]

Enrollment: 441
Study Start Date: February 2005
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
Detailed Description:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk

  Eligibility

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

Inclusion Criteria:

  • Known, specified risk factors for PONV (post operative nausea and vomiting)
  • Undergoing gynecologic or gallbladder surgery.

Exclusion Criteria:

  • pregnant or breastfeeding
  • post-menopausal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274690

  Show 44 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00274690     History of Changes
Other Study ID Numbers: NKT102245
Study First Received: January 9, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neurokinin-1 Receptor Antagonist
GW679769
Post-operative Nausea
NK-1 Receptor Antagonist
 PONV
Post-discharge Nausea and Vomiting
PDNV
Vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
 Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013