Phase 3
N=255
Sudden Deafness Treatment Trial
Sudden Deafness
Bottom Line
View on ClinicalTrials.gov: NCT00097448 ↗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
| Outcome | Result | p-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
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.