Clinical trial NCT01174979: Caroverin and Inner Ear Diseases
Official title: Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Tinnitus
Keywords: Morbus Meniere
Sudden hearing loss
Blast injury
Presbyacusis
Chron. Otitis Media
Lead sponsor: Phafag AG
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: to investigate the time from the start of treatment to an improvement in tinnitus
timeFrame: treatment takes 5 days, follow up examination 4 weeks after
measure: to investigate the efficacy of Caroverin depending the origin of tinnitus
timeFrame: treatment takes 5 days, follow up examination 4 weeks after
measure: to investigate the safety of Caroverin treatment
timeFrame: treatment takes 5 days, follow up examination 4 weeks after
measure: to investigate the impact of Caroverin treatment of quality of life
timeFrame: treatment takes 5 days, follow up examination 4 weeks after
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
state: Vorarlberg
Study officials:
affiliation: Landeskrankenhaus Feldkirch
name: Wolfgang Elsaesser, Dr.
role: PRINCIPAL_INVESTIGATOR
References: