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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05229458
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years old(inlcusiveā„18years).
* Men or women.
* 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 osteoarthritis at both knees, only the most painful one will be included in the study.
* VAS knee painā„40mm at screening and 30 days before.
* Patients willing and able to comply with study terms.
* Patients willing to discontinue all other degenerative joint diseases or knee osteoarthritis treatments.
Exclusion Criteria:
* Patients that are unable or unwilling to provide informed consent and/or patients participating in a concurrent clinical trial and/or patients that have participated in a similar clinical trial within the last 30 days.
* Patients with known hypersensitivity to any components of investigational product.
* Patients with infected or severely inflamed joints
* Patients with skin diseases or infections in the area of the injection site.
* Patients with hepatic failure or history thereof.
* Protected persons defined in the following articles of the French Public Health Code:
* L. 1121-5 pregnant women or breastfeeding.
* L. 1121-6: persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research.
* L. 1121-7: minors.
* L. 1121-8: adults who are subject to legal protection measures or out of state to express their consent.
* L. 1122-1-2: people in emergency situations who cannot give prior consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05229458
Study Brief:
Protocol Section:
NCT05229458