Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

July 9, 2009 updated by: GlaxoSmithKline

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 737-0811
        • GSK Investigational Site
      • Hokkaido, Japan, 060-8543
        • GSK Investigational Site
      • Hokkaido, Japan, 060-0061
        • GSK Investigational Site
      • Hokkaido, Japan, 073-0164
        • GSK Investigational Site
      • Hyogo, Japan, 655-0004
        • GSK Investigational Site
      • Ibaraki, Japan, 300-0053
        • GSK Investigational Site
      • Kagawa, Japan, 760-0017
        • GSK Investigational Site
      • Kagoshima, Japan, 890-0061
        • GSK Investigational Site
      • Kagoshima, Japan, 892-8580
        • GSK Investigational Site
      • Nara, Japan, 630-0227
        • GSK Investigational Site
      • Osaka, Japan, 589-8511
        • GSK Investigational Site
      • Osaka, Japan, 540-0006
        • GSK Investigational Site
      • Osaka, Japan, 565-0871
        • GSK Investigational Site
      • Osaka, Japan, 590-0132
        • GSK Investigational Site
      • Osaka, Japan, 598-0048
        • GSK Investigational Site
      • Osaka, Japan, 560-0055
        • GSK Investigational Site
      • Saitama, Japan, 351-0102
        • GSK Investigational Site
      • Tokyo, Japan, 152-0021
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
  • General or urologic surgery
  • Cancer surgery
  • Gynecologic surgery
  • Radical surgery for pelvic malignancy

Exclusion criteria:

  • Active, clinically significant bleeding Thrombocytopenia Body weight <40kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Venous thromboembolism and Major bleeding
Time Frame: Throughout entire study
Throughout entire study

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Time Frame: Throughout entire study
Throughout entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR3106116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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