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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT03528369
Eligibility Criteria:
Inclusion Criteria:
* Osteoarthritis (OA) of both knees;
* OA of both knees must be confirmed by tibiofemoral joint radiographs obtained within the past 6 months;
* Rheumatoid factor (RF) negative and Erythrocyte sedimentation rate (ESR) \<40 mm/hr;
* Chronic knee pain in at least 1 knee for \> 3 months;
* WOMAC pain score of \> 250 (using VAS WOMAC format) at screening, and at baseline, in at least one knee;
* Knee pain score of \> 5 on the NRS pain scale at screening, and at baseline, in at least one knee;
* Knee pain is not potentially due to acute trauma unrelated to OA (no acute traumatic knee injury in medical history);
* No burning-stinging pain, unrelated to subject's knee pain, at intended site of application;
* Knee pain must be greater than pain in any other part of subject's body;
* American College of Rheumatology (ACR) global functional status I, II, or III (excluding IV).
Exclusion Criteria:
* Spontaneously improving or rapidly deteriorating OA of the knee;
* Rheumatoid or psoriatic arthritis, or a form of arthritis (e.g. gout, pseudogout), Paget's disease of bone, or any other disease affecting the joints that are inconsistent with a diagnosis of idiopathic OA;
* Labile or poorly controlled hypertension;
* Use of steroids for 1 month prior to screening, or intraarticular-visco-supplementation within 3 months prior to screening;
* Used any capsaicin-containing product on or in the vicinity of the knee within 4 weeks prior to screening;
* Used topically applied products (including emollients or moisturizers) on or in the vicinity of the knees or shaved the knees within 2 days prior to the first application of study drug; or an open wound near the knee; cutaneous erythema or edema; any inflammatory skin lesions such as eczema or psoriasis; cutaneous infections; or any other compromise of the skin;
* Requires or anticipates any surgical procedure within 3 months prior to screening, has had surgery on the affected joint within 6 months prior to screening, has a prosthesis in either knee, or would require surgery while participating in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT03528369
Study Brief:
Protocol Section:
NCT03528369