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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Neoplasms

Intervention: enoxaparin (Drug); Physical prophylaxis (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
International Clinical Development, Clinical Study Director, Study Director, Affiliation: Sanofi

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.

Clinical Details

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 design: Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Venous thromboembolism incidence

Secondary outcome: 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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Tokyo, Japan
Additional Information

Starting date: March 2007
Last updated: April 2, 2010

Page last updated: August 23, 2015

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