Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
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
2 other identifiers
interventional
23
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2003
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFebruary 5, 2008
February 1, 2008
2.8 years
June 9, 2006
February 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pure tone audiometric threshold
Secondary Outcomes (3)
Word recognition (speech audiometry)
tinnitus improvement
adverse events (worsening of hearing and/or vertigo and/or tinnitus, middle ear inflammation, pain)
Interventions
Eligibility Criteria
You may qualify if:
- 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))
You may not qualify if:
- 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 of any conditions or symptoms which indicate that the hearing loss is not ISSNHL, for example, acoustic trauma, Meniere's disease, fluctuating hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion, hearing loss due to ear surgery, perilymph fistula or barotrauma.
- Pulse synchronic tinnitus (potentially due to glomus jugulare tumor)
- Previous otologic surgery (excluding ventilation tubes)
- History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.
- Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
- Use of non-permitted treatment during the study
- Intake of experimental drugs or participation in a clinical study within the last 30 days
- Only hearing ear
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Vincentius Kliniken, Klinik für HNO Heilkunde
Karlsruhe, 76042, Germany
Department of Otorhinolaryngology, University of Tubingen
Tübingen, 72076, Germany
Bundeswehrkrankenhaus Ulm
Ulm, 89081, Germany
Related Publications (1)
Plontke SK, Lowenheim H, Mertens J, Engel C, Meisner C, Weidner A, Zimmermann R, Preyer S, Koitschev A, Zenner HP. Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy. Laryngoscope. 2009 Feb;119(2):359-69. doi: 10.1002/lary.20074.
PMID: 19172627DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 12, 2006
Study Start
October 1, 2003
Primary Completion
July 1, 2006
Study Completion
July 1, 2007
Last Updated
February 5, 2008
Record last verified: 2008-02