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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: July 24, 2008
Last updated: April 2, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Abdominal Neoplasms
Drug: enoxaparin
Other: Physical prophylaxis
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Venous thromboembolism incidence [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: enoxaparin
20 mg twice a day
Intermittent Pneumatic Compression (IPC)
Other: Physical prophylaxis


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00723216

Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Study Director: International Clinical Development, Clinical Study Director Sanofi
  More Information

Responsible Party: International Clinical Development, Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00723216     History of Changes
Other Study ID Numbers: EFC10094 
Study First Received: July 24, 2008
Last Updated: April 2, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
venous thromboembolism
curative surgery

Additional relevant MeSH terms:
Abdominal Neoplasms
Venous Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Neoplasms by Site
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016