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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00669032
Eligibility Criteria:
Inclusion Criteria:
* Patient \> 45 years of age
* Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
* Joint Space Width (JSW) \> 2mm
* Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation
Exclusion Criteria:
* Overweight patients (body mass index \> 32).
* Pregnant and lactating women. Women of child-bearinge age not using effective contraception
* Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
* AINE administration within the 14 days prior to their inclusion in the study.
* Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
* Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
* Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
* Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
* Patients with severely impaired central nervous system.
* Patients with coagulation alterations, despite receiving treatment.
* Patients with secondary osteoarthritis of the knee
* Patients having previously received surgery, including arthroscopy
* Patients with articular inflammatory disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT00669032
Study Brief:
Protocol Section:
NCT00669032