A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea (NCT02817347) | Clinical Trial Compass
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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients achieving cessation of otorrhea on Day 15.