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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.
EU CTIS ID: 2024-513063-45-00
What this study is testing
To demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with acute ankle sprains based on Sum of Pain Intensity Difference (SPID) of Visual Analogue Scale (VAS) score on pain-on-movement (POM) over 0-48 hours.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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)
You likely can't join 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
- 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).
- excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- patients with a blood coagulation disorder
- patients who use any impermissible medication
See the full eligibility 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.
- 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
- 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).
- excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- patients with a blood coagulation disorder
- patients who use any impermissible medication
- current skin disorder or shaving hair at application site
- history of excessive sweating/hyperhidrosis inclusive of application site
- intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or systemic 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 (RICE allowed)
- participation in a clinical study within 30 days before inclusion in the study or concomitantly
- pregnant and lactating women
- participation in this clinical study in another center
- drug or alcohol abuse in the opinion of the Investigator
- known allergy to paracetamol and galenic components of the rescue medication
- women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception (as defined in the clinical trial protocol)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.