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Phase 3 N=255 Randomized Treatment

Sudden Deafness Treatment Trial

Sudden Deafness

Enrolled (actual)
255
Serious AEs
4.3%
Results posted
Apr 2013
Primary outcome: Primary: Hearing Improvement — 30.7; 28.7 dB

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
prednisone (Drug); methylprednisolone sodium succinate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts Eye and Ear Infirmary
Primary completion
Oct 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Hearing Improvement
30.7; 28.7

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).

Eligibility Criteria

Inclusion Criteria

  • Men/women 18 years and older in good health
  • Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)
  • Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies
  • Symmetric hearing prior to onset of SSNHL
  • Hearing loss must be idiopathic
  • Hearing loss must have occurred within the past 14 days
  • Must be able to read or write English or Spanish

Exclusion Criteria

SYSTEMIC DISEASE

  • >21 days prior oral steroid treatment within preceding 30 days
  • History of tuberculosis (TB) or positive PPD
  • Insulin-dependent diabetes mellitus
  • History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.
  • Serious psychiatric disease or psychiatric reaction to corticosteroids
  • History of heart disease or transient ischemic attacks (TIAs)
  • Prior treatment with chemotherapeutic or immunosuppressive drugs
  • Pancreatitis
  • Active peptic ulcer disease or history of gastrointestinal bleeding
  • History of HIV, Hepatitis B or C
  • Chronic kidney failure
  • Alcohol abuse
  • Active shingles
  • Severe osteoporosis or non-surgical aseptic necrosis of the hip

OTOLOGIC DISEASE

  • Prior history of SSNHL
  • History of fluctuating hearing loss
  • History of Meniere's disease
  • History of chronic ear infection
  • History of otosclerosis
  • History of ear surgery (except childhood pressure equalization [pe] tubes)
  • History of congenital hearing loss
  • History of trauma immediately preceding onset of SSNHL
  • History of syphilitic hearing loss
  • History of genetic/hereditary hearing loss
  • Skull, facial, or temporal bone anomalies
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00097448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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