ENT103 Phase 3 Clinical Study in Patients with Suppurative Otitis Media with Persistent or Prolonged Otorrhea

CEOLIA Pharma Co. Ltd1 个研究点目标入组 200 人开始时间: 待定最近更新: 2022年5月12日

适应症

试验速览

暂无简介。

研究类型: Interventional
干预模型: Multicenter, placebo-controlled, randomized, double-blind comparison study
主要目的: Treatment Purpose

•(1) Patients who are diagnosed with acute otitis media or perforated chronic otitis media caused by an infection.
•(2) Patients who have clinically persistent suppurative otorrhea.
•(3) Patients who obtained a written informed consent on the participation in this clinical study.

•(1) Patients who received antibiotic treatment for acute otitis media, exudative otitis media or perforated chronic otitis media within 3 months prior to enrollment.
•(2) Patients who are diagnosed as eosinophilic otitis media, cholesteatoma otitis media, exudative otitis media or anti-neutrophil cytoplasmic antibody (ANCA) with associated vasculitis not to be treated by anti-microbial medication.
•(3) Patients who have a trend on otitis media of fungal or tubercle bacillus infection (including infection to the tympanic membrane).
•(4) Patients with otitis media with signs of viral infection (including infection to the tympanic membrane).
•(5) Patients who have a mastoiditis.
•(6) Patients who are observed to increase threshold of progressive pure sound bone conduction.
•(7) Patients who are equipped with implantable otologic medical devices such as cochlear implants.
•(8) Patients who have experienced inner ear dizziness within 3 months prior to enrollment.
•(9) Patients who have infections that require systemic treatment with antibiotics.

efficacy Clinical efficacy on elimination of inflammation at middle ear and tympanic membrane

发起方

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