Combined steroid therapy in sudden hearing loss
Phase 1
- Conditions
- Idiopathic Sudden Sensorineural Hearing LossTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2017-000658-20-HU
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Unilateral sensorineural hearing loss (30 dB at three consecutive frequencies) within 72 hours, older than 18 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
Pregnant or breast-feed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to compare hearing result in ISSHL patient who have recieved combined steroid therapy with systemic steroid therapy alone;Secondary Objective: Not applicable;Primary end point(s): Our goal is to prove that hearing recovery after ISSNHL is significantly better in the combination therapy group than in the only systemic therapy group.;Timepoint(s) of evaluation of this end point: 2 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): No further side effects in case of intratympanic steroid application;Timepoint(s) of evaluation of this end point: 2 years