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

NCT ID: NCT00723216

Last Updated: 2010-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Neoplasms

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Enoxaparin

Group Type ACTIVE_COMPARATOR

enoxaparin

Intervention Type DRUG

20 mg twice a day

2

Intermittent Pneumatic Compression (IPC)

Group Type OTHER

Physical prophylaxis

Intervention Type OTHER

Interventions

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enoxaparin

20 mg twice a day

Intervention Type DRUG

Physical prophylaxis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Sanofi-aventis

Principal Investigators

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International Clinical Development, Clinical Study Director

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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EFC10094

Identifier Type: -

Identifier Source: org_study_id

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