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COMPLETEDPHASE3

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.

NCT06866613•Teikoku Seiyaku Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•acute ankle sprains Grade I
•location of injury such that pain-on-movement (POM) is elicited on active standardized movement
•enrollment within 6 hours of the injury
•baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
•adult male or female patients
•age 18 to 64 years (including)
•having given written informed consent
•satisfactory health as determined by the Investigator based on medical history and physical examination.

Exclusion Criteria

•significant concomitant injury in association with the index soft- tissue injury/contusion or strain; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
•current skin disorder or shaving hair at application site
•history of excessive sweating/hyperhidrosis inclusive of application site
•intake of non-steroidal anti-inflammatory drags (NSAIDs) or analgesics within 36 hours, opioids within 7 days, or corticosteroids (except inhaled corticosteroids for e.g. topical treatment of bronchial asthma) within 60 days of inclusion in the study
•intake of long-acting NSAIDs or application of topical medication since the injury (Rest, Ice, Compression, and elevation (RICE) allowed)
•participation in a clinical study within 30 days before inclusion in the study or concomitantly
•participation in this clinical study in another center
•drug or alcohol abuse in the opinion of the Investigator
•pregnant and lactating women
•women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
+16 more criteria

Locations (5)

Medical Practice Ebert

Siemensstr, Bonn, Germany

Medical Practice Prof. Predel

Siemensstr, Bonn, Germany

Medical Practice Schaale-Maas

Siemensstr, Bonn, Germany

Medical Practice Pabst

Sportschule Puch, Fürstenfeldbruck, Germany

Medical Practice Gastl

Römerstraße, Gilching, Germany

Key Dates

Start Date

March 31, 2025

Primary Completion Date

October 18, 2025

Completion Date

October 30, 2025

Last Updated

November 26, 2025

Enrollment

ACTUAL participants

Conditions

Ankle Sprains

Interventions

Esflurbiprofen Topical System (EFTS)

DRUG

Placebo Patch

DRUG

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

NCT06868316

Ankle SprainsAnkle Injuries and Disorders

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RECRUITINGNA

Arthroscopic Versus Open Brostrom for Ankle Instability

NCT03643926

Ankle SprainsInstability, Joint+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Arthroscopic Versus Open Brostrom for Ankle Instability

Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain

The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability

Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability

The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes.