Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
- Registration Number
- NCT01133613
- Lead Sponsor
- Stryker Biotech
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Bone morphogenetic protein 7 0.03 mg/ml BMP-7 or placebo via intraarticular knee injection Cohort 2 Bone morphogenetic protein 7 0.1 mg/ml BMP-7 or placebo via intraarticular knee injection Cohort 3 Bone morphogenetic protein 7 0.3 mg/ml BMP-7 or placebo via intraarticular knee injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States