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Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

NCT02444572 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-07-29

No results posted yet for this study

Summary

Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.

The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.

Study followup duration is up to 30 days post surgical procedure.

Conditions

  • Gastrointestinal Neoplasms
  • Thromboembolic Event

Interventions

DRUG

Enoxaparin 4000 IU

Sponsors & Collaborators

  • Les Laboratoires des Médicaments Stériles

    lead INDUSTRY

Principal Investigators

  • Chadli DZIRI, MD · Charles Nicolle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-07-31
Completion
2020-07-10

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444572 on ClinicalTrials.gov