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

NCT ID: NCT02817347

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-04-13

Brief 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.

Detailed Description

Patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation. Screening should be completed within 7 days prior to randomization.

patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation at randomization visit will be randomized in one of the defined groups.

Conditions

Otitis Media; Otorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

YH1177 (4/0.5%+0.1%)

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

Group Type: EXPERIMENTAL

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

Intervention Type: DRUG

YH1177 (8/1.0%+0.1%)

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

Group Type: EXPERIMENTAL

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

Intervention Type: DRUG

YH1177-D (2/0.25%)

piperacillin 2% + tazobactam 0.25%

Group Type: EXPERIMENTAL

piperacillin 2% + tazobactam 0.25%

Intervention Type: DRUG

YH1177-D (4/0.5%)

piperacillin 4% + tazobactam 0.5%

Group Type: EXPERIMENTAL

piperacillin 4% + tazobactam 0.5%

Intervention Type: DRUG

YH1177-D (8/1.0%)

piperacillin 8% + tazobactam 1.0%

Group Type: EXPERIMENTAL

piperacillin 8% + tazobactam 1.0%

Intervention Type: DRUG

Interventions

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

Intervention Type: DRUG

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

Intervention Type: DRUG

piperacillin 2% + tazobactam 0.25%

Intervention Type: DRUG

piperacillin 4% + tazobactam 0.5%

Intervention Type: DRUG

piperacillin 8% + tazobactam 1.0%

Intervention Type: DRUG

Other Intervention Names

YH1177 (4/0.5%+0.1%); YH1177 (8/1.0%+0.1%); YH1177-D (2/0.25%); YH1177-D (4/0.5%); YH1177-D (8/1.0 %)

Eligibility 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

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

chulho jang, M.D Ph.D

Role: STUDY_CHAIR

Chonnam National Universitiy Hospital

Locations

Chonnam National Universitiy Hospital

Gwangju, Chonnam, South Korea

Countries

South Korea

Other Identifiers

YH1177-201

Identifier Type: -

Identifier Source: org_study_id