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Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs

Inflammation Clinical Trial

Official title:
Randomized, Double Blind, Parallel-groups, Non-inferiority Versus Flector® and Superiority Versus Placebo, Phase III Clinical Trial With Diclofenac Sodium 140 mg Medicated Plaster in Patients With Impact Injuries of the Limbs

Clinical Trial Summary

Phase III, multinational, multicentre, randomized, prospective, double blind, parallel groups, placebo-controlled study to evaluate the analgesic effects of Test Diclofenac Sodium 140mg medicated plaster, Reference DIEP 180 mg medicated plaster, Flector® and Placebo plaster in patients with painful and phlogistic disease due to acute traumatic events of the limbs.

Clinical Trial Description

This will be a Phase III, multinational, multicentre, randomized, prospective, double blind, parallel groups, placebo-controlled study to evaluate the analgesic effects of Test Diclofenac Sodium 140mg medicated plaster (once a day), Reference DIEP 180 mg medicated plaster, Flector® (once a day) and Placebo plaster once a day (i.e. the placebo arm) in patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04976088
Study type Interventional
Source Fidia Farmaceutici s.p.a.
Contact
Status Completed
Phase Phase 3
Start date May 25, 2018
Completion date October 27, 2018
View Details
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