drugset / Trial / NCT02817347

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

NCT02817347

Phase 1/2 Terminated 135 enrolled Yuhan Corporation
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 % Topical
Subject Piperacillin Small molecule 2 % Topical
Subject Piperacillin Small molecule 4 % Topical
Subject Piperacillin Small molecule 8 % Topical
Subject Tazobactam Small molecule 0.25 % Topical
Subject Tazobactam Small molecule 0.5 % Topical
Subject Tazobactam Small molecule 1 % Topical