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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333021
• Other study ID #: AR3106116
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2006
• Last updated: July 9, 2009
• Start date: May 2006
• Est. completion date: February 2007

Study information

• Verified date: July 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux sodium

• GSK576428

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Nara
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Venous thromboembolism and Major bleeding		Throughout entire study
Secondary	Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism		Throughout entire study