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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00723216
First received: July 24, 2008
Last updated: April 2, 2010
Last verified: April 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Enoxaparin
 Drug: enoxaparin
20 mg twice a day
2
Intermittent Pneumatic Compression (IPC)
 Other: Physical prophylaxis

  Eligibility

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

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

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

No publications provided

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:
Prevention
venous thromboembolism
curative surgery

Additional relevant MeSH terms:
Abdominal Neoplasms
Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Neoplasms by Site
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
 Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013