CClinicalTrials.gg
CompletedNCT00333021Updated Jul 10, 2009

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

A Phase 3 interventional study of Fondaparinux sodium and GSK576428 in Venous Thromboembolism, sponsored by GlaxoSmithKline. Completed at 18 sites in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Fondaparinux Abdominal surgery Japanese VTE
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 127 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

  • Active, clinically significant bleeding Thrombocytopenia Body weight \<40kg
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Interventions

  • DrugFondaparinux sodium
  • DrugGSK576428

    Also known as: Fondaparinux sodium

06

What researchers measure

Primary outcomes

  1. Incidence of Venous thromboembolism and Major bleeding

    Time frame: Throughout entire study

Secondary outcomes

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

    Time frame: Throughout entire study

07

Study locations

18 sites
  • GSK Investigational Site
    Hiroshima, 737-0811, Japan
  • GSK Investigational Site
    Hokkaido, 060-0061, Japan
  • GSK Investigational Site
    Hokkaido, 060-8543, Japan
  • GSK Investigational Site
    Hokkaido, 073-0164, Japan
  • GSK Investigational Site
    Hyogo, 655-0004, Japan
  • GSK Investigational Site
    Ibaraki, 300-0053, Japan
  • GSK Investigational Site
    Kagawa, 760-0017, Japan
  • GSK Investigational Site
    Kagoshima, 890-0061, Japan
  • GSK Investigational Site
    Kagoshima, 892-8580, Japan
  • GSK Investigational Site
    Nara, 630-0227, Japan
  • GSK Investigational Site
    Osaka, 540-0006, Japan
  • GSK Investigational Site
    Osaka, 560-0055, Japan
  • GSK Investigational Site
    Osaka, 565-0871, Japan
  • GSK Investigational Site
    Osaka, 589-8511, Japan
  • GSK Investigational Site
    Osaka, 590-0132, Japan
  • GSK Investigational Site
    Osaka, 598-0048, Japan
  • GSK Investigational Site
    Saitama, 351-0102, Japan
  • GSK Investigational Site
    Tokyo, 152-0021, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00333021
Lead sponsor
GlaxoSmithKline
First posted
Jun 2, 2006
Start date
May 2006
Completion
Feb 2007
Last update
Jul 10, 2009

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion