Overview

A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of otorrhea after ear-drop administration of YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yuhan Corporation
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Penicillanic Acid
Piperacillin
Tazobactam
Criteria
Inclusion Criteria:

- Signed Written Informed Consent A detailed explanation about the study, including the
study purpose and procedures and drug properties, had been provided, and the patient
gave voluntary written informed consent.

- Target Population Patients with otitis media presenting with otorrhea, as evidenced by
otoscopy, who had tympanostomy tube insertion or tympanic perforation

- Sex and age Male or female patients 19 years of age or older at screening Women of
childbearing potential (WOCBP) must have 'negative' pregnancy test at screening, and
use an acceptable method of contraception throughout the study.

Exclusion Criteria:

- Excluded Disease

1. Patients diagnosed with otitis media with cholesteatoma, otitis media with
effusion or otitis externa at screening

2. Patients who had a otologic surgery within 1 year prior to screening (except for
tympanostomy tube insertion)

3. Subjects who previously had cholesteatoma or mastoid surgery

- Medical History and Concurrent Disease

1. Patients with complication of labyrinthine fistula at screening

2. Patients with clinically significant medical or mental illness.

3. Patients with infectious disease requiring the use of systemic antimicrobial
therapy

- Physical and Laboratory Test Results

a)Clinically significant finding based on the principal investigator/investigator's
opinion.

- Allergies and Adverse Drug Reactions

1. Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity)

2. History of hypersensitivity to penicillins or -lactamase inhibitors.

3. History of serious skin reaction such as Stevens-Johnson syndrome or toxic
epidermal necrosis

- Prohibited Therapies and/or Medication

1. Patients undergoing a ventilation tube insertion on the day of screening

2. Patients with ventilation tube containing silver oxide or silver salt (e.g.,
T-type tube)

- Reproductive status, Women only

a)Woman of childbearing potential (WOCBP) who is unable, or unwilling to use an
acceptable method of contraception during the study

- Other Exclusion Criteria

1. History of alcohol or drug abuse/addiction within the last 1 year prior to the
study entry

2. Patient who, in the investigator's opinion, is not suitable for the study for any
reason (e.g., ECG or hepatitis test results at screening)