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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01893905
Eligibility Criteria:
Inclusion Criteria:
* Patient \>= 45 years .
* Primary OA of the knee according to ACR criteria.
* OA radiological grade II-III according to Kellgren and Lawrence.
* Patients with moderate-severe pain.
Exclusion Criteria:
* Patients with clinical significant trauma or surgery in the target knee.
* Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.
* Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
* Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections.
* Clinical diagnosis established of uncontrolled diabetes mellitus.
* Patients with asthma.
* History of hypersensitivity to the active drugs or any excipients of the formulations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01893905
Study Brief:
Protocol Section:
NCT01893905