Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-017319-13

Femme et Homme

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Extrait

To evaluate the safety and efficacy of topical Moxidex for the treatment of patients with acute otitis media with tympanostomy tubes (AOMT); To demonstrate the therapeutic superiority of Moxidex relative to Moxifloxacin based on clinical cures at end of treatment (EOT); To demonstrate therapeutic superiority of Moxifloxacin relative to Vehicle based on clinical cures at EOT.


Critère d'inclusion

  • Acute otitis media with otorrhea in tympanostomy tubes