NCT02444572

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

Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Les Laboratoires des Médicaments Stériles · Industry
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Enoxaparin 4000 IU

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-07-01
• Completion: 2020-07-10
• First posted: 2015-05-14
• Last updated: 2021-07-29

Locations

1 site across 1 country: Tunisia