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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00723216

Enrollment

151

Registered

2008-07-28

Start date

2007-03-31

Completion date

2007-12-31

Last updated

2010-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Neoplasms

Keywords

Prevention, venous thromboembolism, curative surgery

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.

Interventions

DRUGenoxaparin

20 mg twice a day

OTHERPhysical prophylaxis

Study design

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Venous thromboembolism incidence	28 days

Secondary

Measure	Time frame
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	28 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026