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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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