Back to resultsJapanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
Primary Purpose
Abdominal Neoplasms
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
enoxaparin
Physical prophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Neoplasms focused on measuring Prevention, venous thromboembolism, curative surgery
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1
2
Arm Description
Enoxaparin
Intermittent Pneumatic Compression (IPC)
Outcomes
Primary Outcome Measures
Venous thromboembolism incidence
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00723216
Brief Title
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Neoplasms
Keywords
Prevention, venous thromboembolism, curative surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Enoxaparin
Arm Title
2
Arm Type
Other
Arm Description
Intermittent Pneumatic Compression (IPC)
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
20 mg twice a day
Intervention Type
Other
Intervention Name(s)
Physical prophylaxis
Primary Outcome Measure Information:
Title
Venous thromboembolism incidence
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
International Clinical Development, Clinical Study Director
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
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