ENT103 Phase 3 Clinical Study in Patients with Suppurative Otitis Media with Persistent or Prolonged Otorrhea
- Conditions
- Otitis media
- Registration Number
- JPRN-jRCT2080224658
- Lead Sponsor
- CEOLIA Pharma Co. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 200
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Clinical efficacy on elimination of inflammation at middle ear and tympanic membrane
- Secondary Outcome Measures
Name Time Method efficacy<br>Duration until stopping otorrhea<br>efficacy<br>Bacteriological effects (bacterial loss rate, MIC for causative bacteria)<br>efficacy<br>Properties on otorrhea