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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01113333
Eligibility Criteria:
Inclusion criteria:
* Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:
* X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,
* Western Ontario MacMaster (WOMAC) score ≦ 72,
* American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.
Exclusion criteria:
* Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
* Secondary osteoarthritis.
* Moderate/severe renal impairment.
* Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) \> 3 Upper Limit of Normal range.
* Intra-articular injection within 3 months.
* Presence of local skin abnormality at the affected knee joint.
* Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.
* Any Investigational Product within 3 months.
* Any patient unlikely to comply with the requirements of the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01113333
Study Brief:
Protocol Section:
NCT01113333