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Caroverin and Inner Ear Diseases

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Phafag AG
ClinicalTrials.gov Identifier:
NCT01174979
First received: August 2, 2010
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Tinnitus
 Drug: Caroverin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Phafag AG:

Primary Outcome Measures:
  • to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale. [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to investigate the time from the start of treatment to an improvement in tinnitus [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ] [ Designated as safety issue: No ]
  • to investigate the efficacy of Caroverin depending the origin of tinnitus [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ] [ Designated as safety issue: No ]
  • to investigate the safety of Caroverin treatment [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ] [ Designated as safety issue: Yes ]
  • to investigate the impact of Caroverin treatment of quality of life [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caroverin Drug: Caroverin
treatment with eardrops 2 times for 48 hours
Placebo Comparator: Placebo Drug: Caroverin
treatment with eardrops 2 times for 48 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174979

Locations
Austria
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria, 6800
Sponsors and Collaborators
Phafag AG
Investigators
Principal Investigator: Wolfgang Elsaesser, Dr. Landeskrankenhaus Feldkirch
  More Information

No publications provided

Responsible Party: Prim. Dr. Wolfgang Elsaesser, LKH Feldkirch
ClinicalTrials.gov Identifier: NCT01174979     History of Changes
Other Study ID Numbers: 1-09, 2009-018046-38
Study First Received: August 2, 2010
Last Updated: November 18, 2011
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Austria: Ethics Commitee Vorarlberg

Keywords provided by Phafag AG:
Morbus Meniere
Sudden hearing loss
Blast injury
Presbyacusis
Chron. Otitis Media

Additional relevant MeSH terms:
Labyrinth Diseases
Tinnitus
Ear Diseases
Otorhinolaryngologic Diseases
Hearing Disorders
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013