Caroverin and Inner Ear Diseases

Phafag AG

Status and phase

Suspended

Phase 3

Conditions

Tinnitus

Treatments

Drug: Caroverin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174979

1-09

2009-018046-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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