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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT07096050
Eligibility Criteria:
Inclusion Criteria:
1. Patients older than 18 years old (inclusive ≥ 18 years).
2. Men or women.
3. Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases (clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with OA at both knees, only the most painful one will be included in the study.
4. VAS knee pain ≥ 40 mm at screening and 30 days before.
5. Patients willing and able to comply with study terms.
6. Patients willing to discontinue all other OA treatments
Exclusion Criteria:
1. Patients that are unable or unwilling to provide informed consent, and/or patients participating in a concurrent clinical trial and/or patients who have participated in a similar clinical trial within the last days.
2. Patients with known hypersensitivity to any components of investigational product.
3. Patients who are pregnant or breastfeeding. Patients with infected or severely inflamed joints.
4. Patients with skin diseases or infections in the area of the injection site.
5. Patients with hepatic failure or history thereof.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07096050
Study Brief:
Protocol Section:
NCT07096050