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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01860833
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for the study were:
* older than 50 years and
* had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
Further inclusion criteria were:
* clinical signs of joint inflammation (warmth, swelling or effusion) and
* a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Exclusion Criteria:
* allergy to NSAIDs,
* progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
* history of gastrointestinal ulcer or bleeding,
* a hemoglobin concentration lower than 11.5 g/dL,
* renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
* liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01860833
Study Brief:
Protocol Section:
NCT01860833