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.
Phase 3
40 Years
N/A
40 Years
N/A
Not Enrolling
Both
Abdominal Neoplasms
Both
Abdominal Neoplasms
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Venous thromboembolism incidence
Outcome Time Frame:
28 days
Safety Issue:
No
Principal Investigator
International Clinical Development, Clinical Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
EFC10094
NCT ID:
NCT00723216
Start Date:
March 2007
Completion Date:
December 2007
Related Keywords:
- Abdominal Neoplasms
- Prevention
- venous thromboembolism
- curative surgery
- Abdominal Neoplasms
- Neoplasms
- Thromboembolism
- Venous Thromboembolism
- Venous Thrombosis
Name | Location |
|---|
