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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00992004
Eligibility Criteria:
Inclusion Criteria:
* Patient is 40 through 80 years of age
* Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
* Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
* Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
* Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
* Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
* Patients having signed the informed consent,
* Patients capable of comprehend the study instructions.
Exclusion Criteria:
* Related to the osteoarthritis pathology:
* Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
* Predominant associated symptomatic femoropatellar osteoarthritis,
* Chondromatosis or villonodular synovitis of the knee,
* Recent trauma (\< 1 month) of the knee responsible for the pain,
* Knee joint effusion justifying an evacuation through puncturing,
* Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
* Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
* Related to previous and associated treatments:
* Corticosteroids injection in the previous month, whatever the joint concerned,
* Hyaluronan injection in the evaluated knee during the previous 6 months,
* Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
* Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
* Anticoagulant treatment without gastric protection,
* General corticotherapy,
* Contraindication to paracetamol.
* Related to associated pathologies:
* Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
* Peptic ulcer.
* Related to patients:
* Pregnant or breastfeeding women
* Pre-menopausal women with no contraception
* Patients unable to write
* Patients enrolled in a clinical trial in the previous 3 months
* Patients under juristic protection or under guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00992004
Study Brief:
Protocol Section:
NCT00992004