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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00941746 | Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain | PHASE1 | COMPLETED | 56 | — | — | Aug 1, 2009 | Jan 1, 2011 | Jun 7, 2011 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| Lowest dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Second dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Third dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Fourth dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Fifth dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Top dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Placebo | EXPERIMENTAL | single, slow intravenous infusion that matches PG110 in appearance |
| Seventh Dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Eight Dose of PG110 | EXPERIMENTAL | single, slow intravenous infusion |
| Name | Type | Description |
|---|---|---|
| PG110 | BIOLOGICAL | Single, slow intravenous infusion |
| Placebo | BIOLOGICAL | Single, slow intravenous infusion that matches PG110 in appearance |
Inclusion Criteria: * Moderate to severe pain attributed to knee osteoarthritis Exclusion Criteria: * Significant comorbidity * Significant pain states other than osteoarthritis * Concomitant medications that might affect assessments