Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
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.
Drug: Dexamethasone-dihydrogenphosphate (4mg/ml)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Double Blind, Placebo Controlled, Multicenter Study on the Safety and Efficacy of Continuous Infusion of Corticosteroid Delivered Via Catheter in Patients With Idiopathic Sudden Sensorineural Hearing Loss|
- Pure tone audiometric threshold
- Word recognition (speech audiometry)
- tinnitus improvement
- adverse events (worsening of hearing and/or vertigo and/or tinnitus, middle ear inflammation, pain)
|Study Start Date:||October 2003|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Patients suffering from unilateral severe to profound sudden sensorineural hearing loss (ISSNHL) or anacusis with no or insufficient recovery after 12-21 days after onset will be treated for 14 days with Dexamethasone or placebo delivered intratympanically via a micro-catheter temporarily implanted into the round window niche and an external mini-pump.
Due to the relatively unknown risks of intratympanic treatment by catheter implantation, a significant spontaneous recovery rate and an existing standard therapy for ISSNHL in Germany (systemic glucocorticoids), patients will only be enrolled into the study if no or insufficient recovery of hearing threshold could be observed after initial systemic therapy.
The study will be carried out until 10 patients per group have been randomized regardless in which study center they have been randomized. After the last patient of these 10 patients per group has reached the endpoint an interim analysis will be done. The statistical estimation of the total number of subjects to be randomized will be completed after this interim analysis by the responsible statistician.
|St. Vincentius Kliniken, Klinik für HNO Heilkunde|
|Karlsruhe, Germany, 76042|
|Department of Otorhinolaryngology, University of Tubingen|
|Tubingen, Germany, 72076|
|Ulm, Germany, 89081|
|Principal Investigator:||Hans-Peter Zenner, M.D.||Department of Otorhinolaryngology, University of Tubingen|
|Study Director:||Stefan K Plontke, M.D.||Department of Otorhinolaryngology, University of Tubingen|