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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00456157
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain, and may include crepitus, swelling and/or effusion of the knee. In subjects with bilateral knee OA, the more symptomatic knee is the index knee. Subjects may be taking NSAIDs, analgesics and/or undergoing physical therapy.
* Age \> 40 years
* Radiographic evidence on posteroanterior (PA) and lateral standing, flexed x-rays of at least one osteophyte.
* Subjects must be willing to abstain from other intraarticular treatments of the knee or any surgery for 12 weeks on study.
* Ability to comply with the study and give informed consent.
* Subjects must be willing to abstain from NSAIDs or analgesic medications (except for acetaminophen) for 48 hours prior to assessments, at screening, day 1 and week 4, 8, 12, and 24 visits.
Exclusion Criteria:
* Concurrent medical or arthritic conditions which could interfere with evaluation of the index knee joint including fibromyalgia.
* Subject has received arthroscopic or open surgery to the index joint within 6 months of study start
* The presence of surgical hardware or other foreign body in the index joint
* Corticosteroid, hyaluronic acid or other intraarticular injection within 3 months of study start
* Use of chondroitin and/or glucosamine within 4 weeks prior to study start
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
* Clinical signs and symptoms of active knee infection or crystal disease
* Clinically significant cardiac disease, consult study Medical Monitor
* Have an increased predisposition for the development of infections
* History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
* More significant pain from the back or the hip than the knee
* Skin breakdown at the knee where the injection would take place
* Planned knee replacement during the study period
* For subjects undergoing MRI, the presence of contraindications to having an MRI at the specific imaging facility.
* For subjects undergoing MRI, an estimated Glomerular Filtration Rate (eGFR) of \<45 mL/min calculated using the Cockcroft-Gault estimate for eGFR as follows:
eGFR = (140-age \[yrs\]) X weight \[kg\] / serum creatinine \[mg/dL\] X 72 (X 0.85 for women)
* For subjects undergoing MRI, known allergy to gadolinium contrast material
* Has known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis C or B viruses
* Has participated within 30 days or will participate concurrently in another investigational drug or vaccine study
* Has a history of drug or alcohol dependence in the past 3 years
* Known sensitivity to lidocaine or OP-1
* Female with reproductive capability
* Has other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
* Prior use of a bone morphogenetic protein.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00456157
Study Brief:
Protocol Section:
NCT00456157