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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

July 24, 2008
April 2, 2010
March 2007
December 2007   (final data collection date for primary outcome measure)
Venous thromboembolism incidence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Abdominal Neoplasms
  • Drug: enoxaparin
    20 mg twice a day
  • Other: Physical prophylaxis
  • Active Comparator: 1
    Enoxaparin
    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.
 
Completed
151
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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00723216
EFC10094
No
International Clinical Development, Study Director, Sanofi-aventis
Sanofi
Not Provided
Study Director: International Clinical Development, Clinical Study Director Sanofi
Sanofi
April 2010

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