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

NCT02817347 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2022-01-13

No results posted yet for this study

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

Interventions

DRUG

piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%

DRUG

piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%

DRUG

piperacillin 2% + tazobactam 0.25%

DRUG

piperacillin 4% + tazobactam 0.5%

DRUG

piperacillin 8% + tazobactam 1.0%

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • chulho jang, M.D Ph.D · Chonnam National Universitiy Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-04-13
Completion
2017-04-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02817347 on ClinicalTrials.gov