NCT04908748

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Teikoku Seiyaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Soft Tissue Injuries
• Contusions
• Strains
• Sprains
• Bruises

Interventions

Type	Name	Description
DRUG	Esflurbiprofen Hydrogel Patch	Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-11-09
• Completion: 2021-12-15
• First posted: 2021-06-01
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study