NCT04976088

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Trauma Injury
• Inflammation

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium 140 mg medicated plaster	Test product: Diclofenac Sodium 140 mg medicated plaster, topical application once a day
DRUG	Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector	Reference product: Active-comparator, Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector®, topical application once a day
DRUG	Placebo	Placebo: Placebo plaster, topical application once a day.

Timeline

• Start date: 2018-05-25
• Primary completion: 2018-10-27
• Completion: 2018-10-27
• First posted: 2021-07-26
• Last updated: 2023-10-02

Locations

16 sites across 3 countries: Germany, Hungary, Italy