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

NCT06866613 | Completed Phase 3 FDA Drug

• 2 other identifiers: TK-254RX-03012024-513063-45-00
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Blunt trauma; Soft tissue injuries; sports injuries; NSAIDs; topical patch

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM) over 0-48 hours

  Calculating the area under the curve for the difference of each pain intensity score by 100-mm-Visual Analogue Scale (VAS) on movement from the baseline over 0-48 hours after patch application.

  Day 1 to Day 3

Secondary Outcomes (20)

• 100-mm- Visual Analogue Scale (VAS) score on pain-on-movement (POM)

  Day 1 to Day 8

• 100-mm- Visual Analogue Scale (VAS) score on pain-at-rest (PAR)

  Day 1 to Day 8

• Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM)

  Day 1 to Day 8

• Sum of Pain Intensity Difference (SPID) on pain-at-rest (PAR)

  Day 1 to Day 8

• Pain Intensity Difference (PID) on pain-on-movement (POM)

  Day 1 to Day 8

Study Arms (2)

TK-254RX

EXPERIMENTAL

Esflurbiprofen Topical System 165 mg Esflurbiprofen

Drug: Esflurbiprofen Topical System (EFTS)

Placebo patch

PLACEBO COMPARATOR

Placebo patch does not contain active ingredients but it cannot be distinguished in terms of appearance, consistency, odor, and dosage form

Drug: Placebo Patch

Interventions

Esflurbiprofen Topical System (EFTS) DRUG

One EFTS is applied to the injured area over consecutive 7 days

TK-254RX

Placebo Patch DRUG

One placebo patch is applied to the injured area over consecutive 7 days

Placebo patch

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 long-acting NSAIDs or application of topical medication since the injury (Rest, Ice, Compression, and elevation (RICE) allowed)
• 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:
• Surgical sterilization
• Combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method)
• Total abstinence throughout the study at the discretion of the Investigator
• Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study
• A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of sterilisation, salpingectomy) or 6 months of spontaneous amenorrhea with serum Follic simulating hormone (FSH) levels \> 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the patch
• patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead
• CRM Biometrics GmbH: collaborator
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator
• HWI pharma services GmbH: collaborator
• Clinsearch GmbH: collaborator

Study Sites (5)

Medical Practice Ebert

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Prof. Predel

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Schaale-Maas

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Pabst

Sportschule Puch, Fürstenfeldbruck, 82556, Germany

Location

Medical Practice Gastl

Römerstraße, Gilching, 82205, Germany

Location

MeSH Terms

Conditions

Ankle Injuries; Wounds, Nonpenetrating; Soft Tissue Injuries; Athletic Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Kenichi Nishiyama

  Teikoku Seiyaku Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 10, 2025
• Study Start: March 31, 2025
• Primary Completion: October 18, 2025
• Study Completion: October 30, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)