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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00750633 | A Phase III Study of an Otic Formulation in Acute Otitis Externa | PHASE3 | COMPLETED | 990 | — | — | Jun 1, 2008 | Jan 1, 2009 | Dec 3, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| Moxidex | EXPERIMENTAL | Moxidex otic solution |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin otic solution |
| Dexamethasone | ACTIVE_COMPARATOR | Dexamethasone phosphate otic solution |
| Name | Type | Description |
|---|---|---|
| Moxidex otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Moxifloxacin otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Dexamethasone phosphate otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Tympanostomy tubes | DEVICE | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children |
Inclusion Criteria: * Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin * A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema * Other protocol-defined inclusion criteria may apply Exclusion Criteria:...