Skip to main content
OpenTrials
Completed

NCT Number: NCT00723216

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Neoplasms Cardiovascular Diseases Embolism and Thrombosis Neoplasms Neoplasms by Site Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enoxaparin

Drug

20 mg twice a day

Physical prophylaxis

Other

Primary outcomes

  1. Venous thromboembolism incidence

    Time frame: 28 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2008
Registry last updated
Apr 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.