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

NCT02817347 | Terminated Phase 1

• 1 other identifier: YH1177-201
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media; Otorrhea

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving cessation of otorrhea on Day 15.

  The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy

  Day 15

Secondary Outcomes (6)

• The proportion of patients with cessation of otorrhea on Day 8.

  Day 8

• The proportion of patients with cessation of otorrhea on Day 22.

  Day 22

• Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy

  Day 8

• Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy

  Day 15

• Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy

  Day 22

Other Outcomes (7)

• Cmax

  pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

• AUClast

  pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

• AUCinf

  pre-dose, and at 0.25, 0.5, 1, 2, 4 and 6 hours

Study Arms (5)

YH1177 (4/0.5%+0.1%)

EXPERIMENTAL

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

Drug: piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

YH1177 (8/1.0%+0.1%)

EXPERIMENTAL

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

Drug: piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

YH1177-D (2/0.25%)

EXPERIMENTAL

piperacillin 2% + tazobactam 0.25%

Drug: piperacillin 2% + tazobactam 0.25%

YH1177-D (4/0.5%)

EXPERIMENTAL

piperacillin 4% + tazobactam 0.5%

Drug: piperacillin 4% + tazobactam 0.5%

YH1177-D (8/1.0%)

EXPERIMENTAL

piperacillin 8% + tazobactam 1.0%

Drug: piperacillin 8% + tazobactam 1.0%

Interventions

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1% DRUG

Also known as: YH1177 (4/0.5%+0.1%)

YH1177 (4/0.5%+0.1%)

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1% DRUG

Also known as: YH1177 (8/1.0%+0.1%)

YH1177 (8/1.0%+0.1%)

piperacillin 2% + tazobactam 0.25% DRUG

Also known as: YH1177-D (2/0.25%)

YH1177-D (2/0.25%)

piperacillin 4% + tazobactam 0.5% DRUG

Also known as: YH1177-D (4/0.5%)

YH1177-D (4/0.5%)

piperacillin 8% + tazobactam 1.0% DRUG

Also known as: YH1177-D (8/1.0 %)

YH1177-D (8/1.0%)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Excluded Disease
• Patients diagnosed with otitis media with cholesteatoma, otitis media with effusion or otitis externa at screening
• Patients who had a otologic surgery within 1 year prior to screening (except for tympanostomy tube insertion)
• Subjects who previously had cholesteatoma or mastoid surgery
• Medical History and Concurrent Disease
• Patients with complication of labyrinthine fistula at screening
• Patients with clinically significant medical or mental illness.
• 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
• Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity)
• History of hypersensitivity to penicillins or -lactamase inhibitors.
• History of serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrosis
• Prohibited Therapies and/or Medication

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonnam National Universitiy Hospital

Gwangju, Chonnam, 501-757, South Korea

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Piperacillin; Tazobactam

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones

Study Officials

• chulho jang, M.D Ph.D

  Chonnam National Universitiy Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

KR (1)