Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Abdominal Neoplasms Clinical Trial

Official title:

Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723216
• Other study ID #: EFC10094
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2008
• Last updated: April 2, 2010
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.

Exclusion Criteria:

• surgery under laparoscope and other endoscopic operations

• clinical signs of deep vein thrombosis

• use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration

• severe hepatic disease or renal disease

• women of childbearing potential, pregnant or lactating.

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Venous Thromboembolism

Intervention

Drug:
• enoxaparin
20 mg twice a day

Other:
• Physical prophylaxis

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism incidence		28 days	No
Secondary	Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis		28 days	No