E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ands after approximately one year after the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |