Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With S… (NCT00335920) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
Germany23 participantsStarted 2003-10
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of an intratympanic continuous two-week application of dexamethasone compared to placebo using a temporarily implanted catheter in patients with severe to profound sudden sensorineural hearing loss and insufficient recovery after initial systemic prednisolone therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Signed informed consent form
* Age is greater than 18 years old and less than 75 years old.
* Diagnosis of unilateral Idiopathic sudden sensorineural hearing loss (i.e. sudden sensorineural hearing loss of unknown etiology
* Sensorineural hearing loss is at least 50 dB or more for three or more frequencies in standard pure tone, bone-conducted audiogram within the range of 500 Hz to 4000 Hz (500, 1000, 2000, 3000 and 4000), 60 dB or more for two of these frequencies or 70 dB or more for any frequency within this range, or a decrease in the SRT to 70 dB or greater (not accounted for by conductive hearing loss) or a drop in speech discrimination score to less than or equal to 30%
* hearing loss occurred within 72 hours
* Hearing loss occurred at least 12 days ago but less than or equal to 21 days ago
* Insufficient recovery of the ISSNHL at least 12 days after onset whether or not the patient received Local Standard Therapy (i.e. Hearing in the contralateral ear is at least 20 dB better than the affected ear in at least three frequencies (any three of 500, 1000, 2000, 3000, 4000 Hz))
Exclusion Criteria:
* Age is less than 18 or greater than 75 years old
* Hearing loss occurred less than 12 days or more than 21 days ago
* Positive pregnancy test, risk of pregnancy (insufficient protection or lactation
* Middle ear inflammation or effusion
* Ear canal inflammation
* Conductive hearing loss of greater than 10 dB
* Sudden bilateral hearing loss
* Presence o…