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CompletedNCT00723216Updated Apr 5, 2010

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

A Phase 3 interventional study of enoxaparin and Physical prophylaxis in Abdominal Neoplasms, sponsored by Sanofi. Completed at 1 site in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-04-05.

Sponsored by Sanofi · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
151
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Abdominal Neoplasms

Keywords

  • Prevention
  • venous thromboembolism
  • curative surgery
03

In context

Abdominal Neoplasms

67 studies on the registry are indexed under Abdominal Neoplasms; 18 are open to participants now.

This study's enrollment of 151 is above the median of 74 across 49 interventional studies indexed under Abdominal Neoplasms.

Browse Abdominal Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (actual)

Study arms

  • Active comparator
    1

    Enoxaparin

    Drug: enoxaparin

  • Other
    2

    Intermittent Pneumatic Compression (IPC)

    Other: Physical prophylaxis

Interventions

  • Drugenoxaparin

    20 mg twice a day

  • OtherPhysical prophylaxis
06

What researchers measure

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

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Tokyo, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00723216
Lead sponsor
Sanofi
First posted
Jul 28, 2008
Start date
Mar 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Apr 5, 2010

Study contacts

International Clinical Development, Clinical Study Director
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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