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Phase III Trial to Assess the Safety and Efficacy of TK-254RX in Patients With Contusions | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

NCT06871046•Teikoku Seiyaku Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•acute contusion of the upper or lower limbs
•location of injury such that pain-on-movement 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
•size of injury, as assessed by Investigator, ≥ 25 cm² and ≤ 120 cm²
•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; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
•excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
•current skin disorder or shaving hair at application site
•history of excessive sweating/hyperhidrosis inclusive of application site
•intake of 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
•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
+17 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

February 20, 2025

Primary Completion Date

September 22, 2025

Completion Date

October 1, 2025

Last Updated

October 24, 2025

Enrollment

221

ACTUAL participants

Conditions

Contusions

Interventions

Esflurbiprofen Topical System (EFTS)

DRUG

Dermal Wound Closure Using Silkam®

NCT05225714

ContusionsIncision+1 more

View study

COMPLETEDPHASE2

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

NCT04908748

Soft Tissue InjuriesContusions+3 more

View study

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: October 24, 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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