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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00796224 | Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media | PHASE2 | COMPLETED | 38 | — | — | Dec 1, 2008 | Feb 1, 2009 | Feb 18, 2010 | 2 | Costa Rica |
AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.
| Arm | Type | Description |
|---|---|---|
| 1. | ACTIVE_COMPARATOR | 60 mg/kg azithromycin ER (Extended Release)arm |
| 2. | ACTIVE_COMPARATOR | 30 mg/kg azithromycin IR (Immediate Release) arm |
| Name | Type | Description |
|---|---|---|
| 60 mg/kg azithromycin ER | DRUG | subjects taken 60 mg/kg azithromycin ER |
| 30 mg/kg azithromycin IR | DRUG | subjects taken 30 mg/kg azithromycin IR (Immediate Release) |
Inclusion Criteria: * Subjects age 6 months to \< 12 years. * Have clinical signs/symptoms of acute otitis media in at least one ear. * Parent(s)/legal guardian(s) provide written informed consent. Exclusion Criteria: * Clinical significant other disease. * Recent use of investigational drugs, pr...