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:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT02712957
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
* Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;
* Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
* WOMAC pain subscale ≥ 8
* R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70
Exclusion Criteria:
* Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study
* Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;
* Patients with a contra-indication for the use of Naproxen or acetaminophen;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02712957
Study Brief:
Protocol Section:
NCT02712957