drugset / Trial / NCT00967317
Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of Otosynalar®.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-03
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Auris-Sedina | Unknown | — | — |
| Comparator | fluocinolone acetonide | Small molecule | — | Other |