NCT06871046

Phase III Trial to Assess the Safety and Efficacy of TK-254RX in Patients With Contusions

An Open-label, Multi-centric Trial to Assess the Safety and Efficacy of an Esflurbiprofen Topical System (EFTS) in the Local Symptomatic and Short-term Treatment of Pain in Contusions.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Teikoku Seiyaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.

Conditions

• Contusions

Interventions

Type	Name	Description
DRUG	Esflurbiprofen Topical System (EFTS)	One EFTS is applied to the injured area over 7 days

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-09-22
• Completion: 2025-10-01
• First posted: 2025-03-11
• Last updated: 2025-10-24

Locations

5 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study