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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723216
First Posted: July 28, 2008
Last Update Posted: April 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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: None (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.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Venous thromboembolism incidence [ Time Frame: 28 days ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: International Clinical Development, Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00723216     History of Changes
Other Study ID Numbers: EFC10094
First Submitted: July 24, 2008
First Posted: July 28, 2008
Last Update Posted: April 5, 2010
Last Verified: April 2010

Keywords provided by Sanofi:
Prevention
venous thromboembolism
curative surgery

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