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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03190369
Eligibility Criteria:
Inclusion criteria :
* Symptomatic OA of the target knee joint with WOMAC A1 NRS score of \>=4.0 and less than or equal to (\<=) 8.0 as recorded in the baseline period.
* Confirmed by standard X-rays performed within 3 months prior to screening visit: modified Kellgren-Lawrence Numerical Grading System of Grade I-III in the target knee joint.
* According to the American College of Rheumatology (ACR) Criteria.
* With failure to respond adequately to conservative non-pharmacologic therapy and/or simple analgesics, such as acetaminophen.
* Participant was willing and was able to provide signed informed consent prior to any study related procedures being performed.
Exclusion criteria:
* The score of contralateral knee pain (if present) \>3.0 NRS at screening visit.
* Ipsilateral hip OA.
* Participant with systemic corticosteroids within 12 weeks prior to screening visit.
* Participant with injection of IA corticosteroids in the target knee joint within 26 weeks prior to screening visit.
* Concurrent chronic pain conditions with pain score \>3.0 NRS at screening, or peripheral or central neuropathy that may affect sensation of the target knee area, including but not limited to back pain, hip pain, disc herniation, sciatica, diabetic neuropathy, post-stroke pain or fibromyalgia.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03190369
Study Brief:
Protocol Section:
NCT03190369