Caroverin and Inner Ear Diseases

NCT ID: NCT01174979

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

Brief 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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caroverin

Group Type: EXPERIMENTAL

Caroverin

Intervention Type: DRUG

treatment with eardrops 2 times for 48 hours

Placebo

Group Type: PLACEBO_COMPARATOR

Caroverin

Intervention Type: DRUG

treatment with eardrops 2 times for 48 hours

Interventions

Caroverin

treatment with eardrops 2 times for 48 hours

Intervention Type: DRUG

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phafag AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Elsaesser, Dr.

Role: PRINCIPAL_INVESTIGATOR

Landeskrankenhaus Feldkirch

Locations

Landeskrankenhaus Feldkirch

Feldkirch, Vorarlberg, Austria

Countries

Austria

Other Identifiers

2009-018046-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1-09

Identifier Type: -

Identifier Source: org_study_id