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

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.
ClinicalTrials.gov Identifier: NCT00723216
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : April 5, 2010
Information provided by:

July 24, 2008
July 28, 2008
April 5, 2010
March 2007
December 2007   (Final data collection date for primary outcome measure)
Venous thromboembolism incidence [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00723216 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
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.
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.
Not Provided
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Abdominal Neoplasms
  • Drug: enoxaparin
    20 mg twice a day
  • Other: Physical prophylaxis
  • Active Comparator: 1
    Intervention: Drug: enoxaparin
  • 2
    Intermittent Pneumatic Compression (IPC)
    Intervention: Other: Physical prophylaxis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2007
December 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
International Clinical Development, Study Director, Sanofi-aventis
Not Provided
Study Director: International Clinical Development, Clinical Study Director Sanofi
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP