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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Fondaparinux sodium
GSK576428
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Fondaparinux Abdominal surgery Japanese VTE

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Incidence of Venous thromboembolism and Major bleeding

Secondary Outcome Measures

Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism

Full Information

First Posted
June 1, 2006
Last Updated
July 9, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00333021
Brief Title
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
Official Title
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Fondaparinux Abdominal surgery Japanese VTE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fondaparinux sodium
Intervention Type
Drug
Intervention Name(s)
GSK576428
Other Intervention Name(s)
Fondaparinux sodium
Primary Outcome Measure Information:
Title
Incidence of Venous thromboembolism and Major bleeding
Time Frame
Throughout entire study
Secondary Outcome Measure Information:
Title
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Time Frame
Throughout entire study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
737-0811
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
073-0164
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
655-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
890-0061
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
892-8580
Country
Japan
Facility Name
GSK Investigational Site
City
Nara
ZIP/Postal Code
630-0227
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
560-0055
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
590-0132
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
152-0021
Country
Japan

12. IPD Sharing Statement

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

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