Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01111045 | Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee | PHASE2 | COMPLETED | 355 | — | — | Apr 1, 2010 | Aug 1, 2011 | Feb 1, 2012 | 25 | United States |
| NCT01133613 | Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee | PHASE1 | COMPLETED | 51 | — | — | May 1, 2010 | Oct 1, 2011 | Feb 1, 2012 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | 0.03 mg/ml BMP-7, single intraarticular knee injection |
| Arm 2 | ACTIVE_COMPARATOR | 0.1 mg/ml BMP-7, single intraarticular knee injection |
| Arm 3 | ACTIVE_COMPARATOR | 0.3 mg/ml BMP-7, single intraarticular knee injection |
| Arm 4 | PLACEBO_COMPARATOR | 1 ml placebo, single intraarticular knee injection (control) |
| Cohort 1 | EXPERIMENTAL | 0.03 mg/ml BMP-7 or placebo via intraarticular knee injection |
| Cohort 2 | EXPERIMENTAL | 0.1 mg/ml BMP-7 or placebo via intraarticular knee injection |
| Cohort 3 | EXPERIMENTAL | 0.3 mg/ml BMP-7 or placebo via intraarticular knee injection |
| Name | Type | Description |
|---|---|---|
| Bone morphogenetic protein 7 | DRUG | Comparison of different doses of the drug via single intraarticular knee injection |
| Placebo | DRUG | Placebo |
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...