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Oral Statins and Protection From Hearing Loss

NCT04826237 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-05

No results posted yet for this study

Summary

A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.

Conditions

  • Sudden Sensorineural Hearing Loss

Interventions

DRUG

Statin

Oral dose to be taken with methylprednisolone

DRUG

methylprednisolone

oral dose, standard of care

DRUG

dexamethasone

Drug for intratympanic administration

DRUG

Placebo

Capsule the same as for statins but without statin

Sponsors & Collaborators

Principal Investigators

  • Donna Whitlon, Ph.D. · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2025-10-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04826237 on ClinicalTrials.gov