Clinical trial NCT06866613: Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ankle Sprains
Keywords: Blunt trauma
Soft tissue injuries
sports injuries
NSAIDs
topical patch
Lead sponsor: Teikoku Seiyaku Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: CRM Biometrics GmbH
name: SocraTec R&D GmbH
name: SocraMetrics GmbH
name: HWI pharma services GmbH
name: Clinsearch GmbH
First posted: 2025-03-10
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM) over 0-48 hours
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: 100-mm- Visual Analogue Scale (VAS) score on pain-on-movement (POM)
timeFrame: Day 1 to Day 8
measure: 100-mm- Visual Analogue Scale (VAS) score on pain-at-rest (PAR)
timeFrame: Day 1 to Day 8
measure: Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM)
timeFrame: Day 1 to Day 8
measure: Sum of Pain Intensity Difference (SPID) on pain-at-rest (PAR)
timeFrame: Day 1 to Day 8
measure: Pain Intensity Difference (PID) on pain-on-movement (POM)
timeFrame: Day 1 to Day 8
measure: Pain Intensity Difference (PID) on pain-at-rest (PAR)
timeFrame: Day 1 to Day 8
measure: Time to meaningful/optimal reduction
timeFrame: Day 1 to Day 8
measure: Time to complete resolution
timeFrame: Day 1 to Day 8
measure: Responder rate 1
timeFrame: Day 3
measure: Responder rate 2
timeFrame: Day 8
measure: Resolution of ankle sprain
timeFrame: Day 8
measure: Global efficacy assessments 1 by investigator
timeFrame: Day 3, Day 4 and Day 8
measure: Global efficacy assessments 2 by investigator
timeFrame: Day 3, Day 4 and Day 8
measure: Global efficacy assessments 1 by patients
timeFrame: Day 3, Day 4 and Day 8
measure: Global efficacy assessments 2 by patients
timeFrame: Day 3, Day 4 and Day 8
measure: Number of use of rescue medication
timeFrame: Day 1 to Day 8
measure: Number of patients who experience adverse event and serious adverse event
timeFrame: Day 1 to Day 8
measure: Characterization of local tolerability
timeFrame: Day 8
measure: Patch adhesion assessed by the site staff
timeFrame: Day 2 to Day 5
measure: Patch adhesion assessed by patient
timeFrame: Day 1 to Day 8
Other outcomes:
Locations:
city: Siemensstr
country: Germany
facility: Medical Practice Ebert
state: Bonn
city: Siemensstr
country: Germany
facility: Medical Practice Prof. Predel
state: Bonn
city: Siemensstr
country: Germany
facility: Medical Practice Schaale-Maas
state: Bonn
city: Sportschule Puch
country: Germany
facility: Medical Practice Pabst
state: Fürstenfeldbruck
city: Römerstraße
country: Germany
facility: Medical Practice Gastl
state: Gilching
Study officials:
affiliation: Teikoku Seiyaku Co., Ltd.
name: Kenichi Nishiyama
role: STUDY_CHAIR
References: