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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02838069
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
* Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
* NSAID washout of at least 2 days before screening/baseline
Exclusion Criteria:
* Previous treatments acting on cartilage or bone metabolism
* Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
* Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
* Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
* Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
* History of joint replacement of the knee or hip within the previous 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT02838069
Study Brief:
Protocol Section:
NCT02838069