New patch could ease ankle sprain pain without pills

NCT ID NCT06866613

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medicated patch containing esflurbiprofen, a pain-relieving drug, against a placebo patch in 69 adults with mild ankle sprains. Participants wore the patch for 7 days. The goal was to see if the patch reduces pain during movement better than a placebo. The trial is already completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
esflurbiprofen topical patch
What this could lead to
If it works, this could provide a convenient, non-oral pain relief option for ankle sprains.
What could go wrong
This is a small, completed Phase 3 trial with only 69 participants. Results may not apply to all sprains or other injuries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

69 people

The number who actually took part.

Started

Mar 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ankle injury Athletic Injuries Soft Tissue Injuries Wounds, Nonpenetrating

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medical Practice Ebert

    Siemensstr, Bonn, 53121, Germany

  • Medical Practice Gastl

    Römerstraße, Gilching, 82205, Germany

  • Medical Practice Pabst

    Sportschule Puch, Fürstenfeldbruck, 82556, Germany

  • Medical Practice Prof. Predel

    Siemensstr, Bonn, 53121, Germany

  • Medical Practice Schaale-Maas

    Siemensstr, Bonn, 53121, Germany

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