Status:
COMPLETED
A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee
Lead Sponsor:
Stryker Biotech
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee.
Detailed Description
Subjects with OA will be recruited and informed consent obtained. During a screening period lasting 1 to 28 days, subjects will undergo medical and arthritis history, physical examination, collection ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00456157
Start Date
March 1 2007
End Date
November 1 2008
Last Update
June 17 2010
Active Locations (3)
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1
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
2
Boston University Medical Center
Boston, Massachusetts, United States, 02118-2526
3
University of orth Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599-7280