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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01406561 | Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy | PHASE3 | COMPLETED | 344 | — | — | Aug 1, 2011 | Dec 1, 2012 | Oct 26, 2018 | 18 | United States |
To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee symptoms as measured by the KOOS Symptoms subscale through Day 30.
To evaluate the safety of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on safety as measured by adverse events.
| Arm | Type | Description |
|---|---|---|
| OMS103HP-S | EXPERIMENTAL | OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery |
| Vehicle Irrigation Solution | PLACEBO_COMPARATOR | Vehicle Irrigation Solution |
| Name | Type | Description |
|---|---|---|
| OMS103HP-S | DRUG | Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery |
| Vehicle | DRUG | 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery |
Inclusion Criteria: 1. Voluntarily provide written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if local...