CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 255 enrolled
Drug / intervention
prednisone +1 moredrug
Likely dose
Prednisone oral for 19 days; methylprednisolone sodium succinate intratympanic (4 injections over 2 weeks)AI-extracted
Key inclusion· 6
  • ✓Age ≥18 years in good health
  • ✓Unilateral sudden sensorineural hearing loss (SSNHL) developing within 72 hours
  • ✓Pure Tone Average (PTA) at 500, 1000, 2000, 4000 Hz ≥50 dB in affected ear, with ≥30 dB worse than contralateral ear in at least one frequency
  • ✓Symmetric hearing prior to SSNHL onset
Key exclusion· 16
  • ✕>21 days of oral steroid treatment within preceding 30 days
  • ✕History of tuberculosis or positive PPD
  • ✕Insulin-dependent diabetes mellitus
  • ✕History of rheumatic disease (rheumatoid arthritis, scleroderma, lupus, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00097448
NCT00097448Phase 3Completed
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Sudden Hearing Loss Multicenter Treatment Trial

Massachusetts Eye and Ear Infirmary·interventional·Posted Nov 24, 2004·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating prednisone and methylprednisolone sodium succinate for Sudden Deafness. Completed, enrolled 255 participants across 14 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSudden Deafness
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2004
Enrollment StartDec 1, 2004
Primary CompletionOct 1, 2009
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.6 years ago

Interventions

prednisonedrug

Oral, 19 days

methylprednisolone sodium succinatedrug

Four intratympanic injections delivered to the middle ear over 2 weeks