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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224658

Enrollment

200

Registered

2019-04-23

Start date

2019-05-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis media

Interventions

investigational material(s) Generic name etc : ENT103 INN of investigational material : - Therapeutic category code : 132 Agents for otic and nasal use Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
efficacy Clinical efficacy on elimination of inflammation at middle ear and tympanic membrane	—

Secondary

Measure	Time frame
efficacy Duration until stopping otorrhea efficacy Bacteriological effects (bacterial loss rate, MIC for causative bacteria) efficacy Properties on otorrhea	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026