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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00226772 | Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction | PHASE3 | COMPLETED | 326 | — | — | Jun 1, 2005 | Mar 1, 2011 | Oct 12, 2012 | 18 | United States, Canada |
| NCT00226759 | Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction | PHASE3 | COMPLETED | 321 | — | — | Nov 1, 2004 | Mar 1, 2011 | Oct 12, 2012 | 20 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| OMS103HP irrigation solution | EXPERIMENTAL | Drug |
| vehicle irrigation solution | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| OMS103HP | DRUG | Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours |
| Vehicle | DRUG | Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours |
Inclusion Criteria: * 15 - 65 years of age * In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery * Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft * Able to partici...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | NA | Undisclosed |