Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery - Full Text View

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 III

MedlinePlus related topics:

Cancer

Drug Information available for:

Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Active Control, Parallel Assignment

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-Aventis:

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:	125
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
1: Active Comparator 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
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-Aventis

Investigators


Study Director:	International Clinical Development, Clinical Study Director	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi-aventis ( International Clinical Development, Study Director )
Study ID Numbers:	EFC10094
First Received:	July 24, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00723216
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Prevention

venous thromboembolism

curative surgery

Study placed in the following topic categories:

Embolism and Thrombosis

Embolism

Vascular Diseases

Venous Thromboembolism

Abdominal Neoplasms

Thrombosis

Thromboembolism

Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Neoplasms

Anticoagulants

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00723216