Evaluating a new topical treatment for 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.
This study is testing a new cream for ankle sprains to see if it can help reduce pain better than a fake treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Teikoku Seiyaku Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Siemensstr, Bonn and 4 other locations) |
| Trial ID | NCT06866613 on ClinicalTrials.gov |
What this trial studies
This multi-center, double-blind, randomized controlled trial aims to assess the efficacy and safety of the Esflurbiprofen Topical System (EFTS) compared to a placebo in patients suffering from acute ankle sprains. The primary goal is to demonstrate that EFTS provides superior pain reduction in these patients. Additionally, the study will evaluate the tolerability and adhesion of the EFTS compared to the placebo. Participants will be enrolled within 6 hours of their injury and must meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 who have sustained a Grade I acute ankle sprain and can provide informed consent.
Not a fit: Patients with significant concomitant injuries or those with certain skin conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve recovery times for patients with ankle sprains.
How similar studies have performed: Other studies evaluating topical treatments for pain management have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Siemensstr, Bonn and 4 other locations
- Medical Practice Ebert — Siemensstr, Bonn, Germany (Recruiting)
- Medical Practice Prof. Predel — Siemensstr, Bonn, Germany (Recruiting)
- Medical Practice Schaale-Maas — Siemensstr, Bonn, Germany (Recruiting)
- Medical Practice Pabst — Sportschule Puch, Fürstenfeldbruck, Germany (Recruiting)
- Medical Practice Gastl — Römerstraße, Gilching, Germany (Recruiting)
Study contacts
- Study coordinator: Hirofumi Fujiwara
- Email: hirofumi-fujiwara@teiyaku.co.jp
- Phone: +813-6264-9123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.