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Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

Soft Tissue Injuries Clinical Trial

Official title:
The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.

Clinical Trial Summary

Objective of this study is: to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries. to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

Clinical Trial Description

Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria. 200 patients will be enrolled (assumes a drop-out-rate of ≤10%). The study will be performed in Germany in 3 sites ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04908748
Study type Interventional
Source Teikoku Seiyaku Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date May 20, 2021
Completion date December 15, 2021
View Details
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