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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT03595618
Eligibility Criteria:
Inclusion Criteria:
* Male participants or female participants of non-childbearing potential and not breastfeeding.
* Body weight \> 40 kg, body mass index (BMI) \< 40 kg/m\^2.
* Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
* History of knee pain for at least 6 months and on the majority of days (\> 50%) during the preceding month.
* Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
* Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
Exclusion Criteria:
* Severe clinical knee malalignment according to the investigator.
* Knee prosthesis already implanted (\< 1 year) or not well-tolerated (contralateral side).
* Knee prosthesis already foreseen within the study period (whichever side).
* Hip prosthesis recently implanted (\< 1 year) or foreseen within the study period (whichever side).
* Previous osteotomy on the inferior limbs (whichever side).
* Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
* Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
* Other pathologies affecting the target knee.
* Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03595618
Study Brief:
Protocol Section:
NCT03595618