Recent Updates
Recently added Catalysts

Bone morphogenetic protein 7

Phase 2

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |Stryker Corporation|Last Updated: Feb 1, 2012

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment406
FDA Designations
No designations recorded
Clinical trial landscape

Bone morphogenetic protein 7 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01111045Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the KneeOsteoarthritis of the Knee
COMPLETED355 Analytics
PHASE2COMPLETED
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
Osteoarthritis of the KneeUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Baseline, and at 24 weeks
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 Endpoints
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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1ACTIVE_COMPARATOR0.03 mg/ml BMP-7, single intraarticular knee injection
Arm 2ACTIVE_COMPARATOR0.1 mg/ml BMP-7, single intraarticular knee injection
Arm 3ACTIVE_COMPARATOR0.3 mg/ml BMP-7, single intraarticular knee injection
Arm 4PLACEBO_COMPARATOR1 ml placebo, single intraarticular knee injection (control)
Cohort 1EXPERIMENTAL0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
Cohort 2EXPERIMENTAL0.1 mg/ml BMP-7 or placebo via intraarticular knee injection
Cohort 3EXPERIMENTAL0.3 mg/ml BMP-7 or placebo via intraarticular knee injection
Interventions
NameTypeDescription
Bone morphogenetic protein 7DRUGComparison of different doses of the drug via single intraarticular knee injection
PlaceboDRUGPlacebo
Unlock Study Design Details
Eligibility Criteria
Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

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. Symptoms must include knee joint pain. * A male or female adult age \>40 years * female subjects of childbearing potential must have a negati...

Countries:United States
Unlock Eligibility Criteria