drugset / Trial / NCT00097448

Sudden Deafness Treatment Trial

NCT00097448 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Timeline

Start
2004-12
Primary completion
2009-10
Completion
2011-03

Outcome

Met primary endpoint

paper Recovery of hearing on oral treatment at 2 months by intention-to-treat analysis was 2.0 dB greater than intratympanic treatment (95.21% upper confidence interval, 6.6 dB). PMID 21610239 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 40 mg/ml Other
Subject Prednisone Other / unclassified 60 mg Oral