Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06192420
Eligibility Criteria:
Inclusion Criteria:
* Acute unilateral Grade 1 or Grade 2 sprain of the lateral ankle.
* \>/=18 years of age.
* Legally competent male or female outpatient.
* Injury occurred within previous 24 hours before first treatment expected.
* Signed Informed Consent.
* After 5 minutes of rest, pain on passive movement by investigator measured by Visual Analog Scale (VAS) \>50 mm.
* Not pregnant or breast-feeding.
Exclusion Criteria:
* Similar injury affecting the same joint within the past 6 months.
* Bilateral ankle injury.
* Grade 3 ankle sprain.
* Fracture of the ankle (It should be excluded by using e.g., the Ottawa Ankle Rules. In case of any doubt the exclusion of fracture by x-ray should be considered as per standard of care).
* Chronic joint disorders such as clinically relevant osteoarthritis or aseptic arthritis
* Disorders that may lead to joint oedema for other reasons than ankle sprain (such as heart failure, thrombosis, lymphedema and others).
* Diagnosis requiring bed rest, hospitalization, surgery, or use of any cast during the planned treatment period.
* Debilitating acute or chronic illness.
* Use of systemic and /or topical corticosteroids in the previous 8 weeks, any analgesics (e.g., paracetamol / acetaminophen) in the previous 24 hours before Screening Visit, or 48 hours in the case of long-acting NSAID, cyclooxygenase type 2 (COX-2) specific inhibitors, or tramadol and other opioids. Low dose acetylsalicylic acid (70 - 100 mg per day) for anti-thrombotic therapy is permitted if doses are stable for the month prior to Screening Visit and planned to be stable during the entire study.
* History of sensitivity to any component of the study drugs (including e.g. paracetamol / acetaminophen intolerance; patients in whom asthma attacks, skin rash or acute rhinitis are triggered by acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs).
* Unwilling or unable to comply with all the requirements of the study protocol.
* Concurrent injury to proximal structures in ipsilateral lower extremity (i.e., concurrent shin, knee, thigh, or hip injury).
* History of ligament avulsion, fracture or surgery to the affected lower extremity.
* Presence of infections and/or skin diseases in the area of the study treatment site (including psoriasis).
* Any previous treatments of the injured ankle, whether topical or systemic, are prohibited except RICE (simultaneous combination of all 4 elements; Rest, Ice, Compression and Elevation; which is restricted to be used until starting treatment with the investigational drug).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06192420
Study Brief:
Protocol Section:
NCT06192420