drugset / Trial / NCT00945802
FST-201 In The Treatment of Acute Otitis Externa
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
Timeline
- Start
- 2009-07-31
- Primary completion
- 2010-07-31
- Completion
- 2010-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ciprofloxacin | Small molecule | 0.3 % | Other |
| Comparator | Dexamethasone | Small molecule | 0.1 % | Other |