NCT06866613

Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.

Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of an Esflurbiprofen Topical System (EFTS) vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Ankle Sprains.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Teikoku Seiyaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, double-blind, randomized controlled trial to evaluate the efficacy and safety of EFTS vs. placebo in patients with ankle sprains. The primary objective of this study is to demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with ankle sprains. The secondary objective is to evaluate tolerability, local tolerability, and adhesion of EFTS vs. placebo.

Conditions

• Ankle Sprains

Interventions

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

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-10-18
• Completion: 2025-10-30
• First posted: 2025-03-10
• Last updated: 2025-11-26

Locations

5 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study