TerminatedPhase 1/2

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

Stopped: Sponsor's decision for the Drug Development.

South Korea135 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Exclusion criteria

✕. 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
✕. 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
✕. Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity)
✕. History of hypersensitivity to penicillins or -lactamase inhibitors.

What they're measuring

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

Timeframe: Day 15

Trial details

NCT IDNCT02817347

SponsorYuhan Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-13

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