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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Casopitant
Neurokinin-1 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014