Caroverin and Inner Ear Diseases

Study Overview
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Brief Summary
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This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom. The study will investigate the transtympanic treatment with a 1,5 % caroverine solution. Each patient will undergo treatment for 2 cycles of 48 hours each.

Official Title
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Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine

Conditions
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Tinnitus

Intervention / Treatment
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* Drug: Caroverin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged at least eighteen Written consent to take part in the study after receiving information from the trial physician One of the following illnesses: Decompensated tinnitus Sudden hearing loss Morbus Menière Blast injury Presbyacusis with Tinnitus Chron. Otitis media Exclusion Criteria: Patients who are not able to give their consent (e.g. dementia, coma, mental disability,…) Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating If there are solid reasons to doubt that the patient would be willing and able to cooperate Known intolerance of/hypersensitivity to caroverine Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study Pulse-synchronous tinnitus Tinnitus caused by malposition of the jaw bone (bruxism) Eardrum perforation Subjects who have previously had a barotraumas, diving accidents or decompression sickness Retrocochlear hearing disorder Patients who have previously had a fracture of the petrous bone Subjects suffering from acute or chronic accompanying conditions which severely impede their general health (NYHA stage IV, cancer, HIV etc.) Accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters, particularly ear conditions, including any conditions affecting the other ear or conditions like HI NYHA stage IV, cancer, HIV, Wallenberg Syndrome, massive Hypotension, Glaucoma.) Accompanying medication that according to the current state of scientific knowledge are likely to affect the measurement techniques used in this study or the results obtained (cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacrynic acid), psycho pharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine, cortisone and/or caroverine within the three days preceding the start of the study) Drug treatment for tinnitus or sudden hearing loss (i.v. and oral) within seven days preceding the start of the study where the total duration of the course is less than four weeks Diseases or conditions that may be associated with an altered perception or processing of stimuli, e.g. mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caroverin<br> | Drug: Caroverin<br>* treatment with eardrops 2 times for 48 hours<br>|
| Placebo Comparator: Placebo<br> | Drug: Caroverin<br>* treatment with eardrops 2 times for 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale. |  | treatment takes 5 days, follow up examination 4 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate the time from the start of treatment to an improvement in tinnitus |  | treatment takes 5 days, follow up examination 4 weeks after | 
| to investigate the efficacy of Caroverin depending the origin of tinnitus |  | treatment takes 5 days, follow up examination 4 weeks after | 
| to investigate the safety of Caroverin treatment |  | treatment takes 5 days, follow up examination 4 weeks after | 
| to investigate the impact of Caroverin treatment of quality of life |  | treatment takes 5 days, follow up examination 4 weeks after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbus Meniere, Sudden hearing loss, Blast injury, Presbyacusis, Chron. Otitis Media