Osteoarthritis of the Knee
Conditions
Brief summary
The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
Interventions
Single intraarticular injection of BMP-7 or placebo on Day 1
Sponsors
Stryker Biotech
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. * \>40 years * Radiographic evidence of at least one osteophyte in either knee at screening
Exclusion criteria
* Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia) * Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily. * Received arthroscopic or open surgery to the index knee within 6 months of screening * History of joint replacement surgery (index knee). * Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening * Long acting hyaluronic acid injection of the index knee within 6 months of screening * History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia. * History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ. * Female subject with reproductive capability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (physical examination, vital signs, clinical laboratory measurements, adverse events) | Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC pain and function | Baseline, Week 4, Week 8, Week 12, Week 24 |
| Patient and physician global VAS | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 |
| Quality of life measurement (SF-36) and pain medication use | Baseline, Week 4, Week 8, Week 12, Week 24 |
Countries
United States
Outcome results
None listed