Caroverin and Inner Ear Diseases (NCT01174979) | Clinical Trial Compass
SuspendedPhase 3
Caroverin and Inner Ear Diseases
Stopped: due to less patient the study was suspended
Austria170 participantsStarted 2011-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.
Timeframe: treatment takes 5 days, follow up examination 4 weeks after