CompletedPhase 1/2

Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

South Korea15 participantsStarted 2021-07-22

Plain-language summary

This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry * Patients whose hearing has not been restored after standard treatment * Patients do not participate in clinical trials within 6 months Exclusion Criteria: * Patients with retrocochlear lesion * Patients with history of hypersensitivity to the ingredients of this drug * Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

What they're measuring

Verification of tympanic membrane with endoscopy (Safety)

Timeframe: 3-4 weeks after intratympanic injection

Confirmation of inflammation and drug with CT imaging (Durability)

Timeframe: 1 day and/or 1 weeks after intratympanic injection

Valuation of hearing threshold with Pure tone audiometry (Efficacy)

Timeframe: 3-4 weeks after intratympanic injection

Trial details

NCT IDNCT04766853

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-18

View on ClinicalTrials.gov More Hearing Loss, Sudden trials