Sudden Deafness Treatment Trial

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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