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

Teikoku Seiyaku

Status and phase: Enrolling; Phase 3

Conditions: Ankle Sprains

Treatments: Drug: Placebo Patch; Drug: Esflurbiprofen Topical System (EFTS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06866613

2024-513063-45-00 (EU Trial (CTIS) Number)

TK-254RX-0301

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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:

  • 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

• history of previous significant injury to the same extremity within 6 months

• patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc.

• patients having an ongoing painful condition associated with blunt injury/contusion

• patients suffering from symptoms of an infectious disease including swelling of any joint of the affected lower limbs

• patients who had surgery of the affected lower limb within one year of study entry

• patients with significant diseases (defined as a disease which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease)

• patients with a blood coagulation disorder

• patients who use any impermissible medication

• known allergy to paracetamol and galenic components of the rescue medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

TK-254RX

Experimental group

Description:

Esflurbiprofen Topical System 165 mg Esflurbiprofen

Treatment:

Drug: Esflurbiprofen Topical System (EFTS)

Placebo patch

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Patch