Caroverine infusions have been used successfully in Austria to treat cochlear-synaptic tinnitus. This treatment is very time consuming and needs a constant monitoring of the physician. This study will investigate the efficacy and safety of caroverine eardrops for transtympanic treatment of tinnitus. The aim is to ascertain whether the results of the proof of concept study using a 1,5 % solution can be reproduced.
Conditions
Interventions
Trade Name: Tinnitin Ampoules
Product Name: Tinnitin or Spasmium
Pharmaceutical Form: Ear drops, solution
INN or Proposed INN: CAROVERINE
CAS Number: 23465761
Other descriptive name: 1-Diethylaminoeth
Sponsors
Phafag AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women aged at least eighteen • Written consent to take part in the study after receiving information from the trial physician • Decompensated tinnitus with a subjective tinnitus rating of 3 to 10 (0 = no tinnitus 10 = agonising tinnitus). • Sudden Hearing Loss • Morbus Menière • Blast injury • Presbyacusis • chron. Otitis media 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 • Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study • Known intolerance of/hypersensitivity to caroverine • Pulse-synchronous tinnitus • Tinnitus caused by malpostition of the jaw bone (bruxism) • Eardrum perforation • Retrocochlear hearing disorder • Patients who have previously had a barotrauma • Diving accident, decompression sickness • Patients who have previously had a fracture of the petrous bone • Subjects suffering from acute or chronic 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 (NYHA stage IV, cancer, HIV etc., Wallenbergsyndrom, Massive hypotension, Glaucoma) • 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 • 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 (e.g. accompanying treatment with cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacryn acid), psychopharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine and/or caroverine within the three days preceding the start of the study) • (Intravenous) drug treatment for tinnitus within the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the efficacy of caroverine in the transtympanic treatment of patients with tinnitus, measured by subjective assessments of tinnitus before treatment, after 48 hours of treatment and during the final examination which will take place within four weeks of the last dose of caroverine.;Secondary Objective: •comparison of remission rates verum vs. placebo •time from start of treatment to an improvement •compare the effect of the treatment concerning the origin of tinnitus (subgroup analysis) •record of possible change of the quality of life (amount of attacks for M. Menière, Speechdiscrimination for Presbyacusis) •record possible subjective and objective adverse events within the aforementioned period and the number of patients which with adverse effects •compare the therapeutic effect of transtympanic caroverine treatment with the results obtained from previous studies and the results described in the literature ;Primary end point(s): Improvement of tinnitus at least 2 points on the subjective VA scale (1-10) after the treatment and at the follow up examination. | — |
Countries
Austria
Outcome results
None listed