Caroverin and Inner Ear Diseases

Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine

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.

Study Overview

• Status: Suspended
• Conditions: Tinnitus
• Intervention / Treatment: Drug: Caroverin

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6800
      • Landeskrankenhaus Feldkirch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Caroverin; treatment with eardrops 2 times for 48 hours
Experimental: Caroverin	Drug: Caroverin; treatment with eardrops 2 times for 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.	treatment takes 5 days, follow up examination 4 weeks after

Secondary Outcome Measures

Outcome Measure	Time Frame
to investigate the time from the start of treatment to an improvement in tinnitus	treatment takes 5 days, follow up examination 4 weeks after
to investigate the efficacy of Caroverin depending the origin of tinnitus	treatment takes 5 days, follow up examination 4 weeks after
to investigate the safety of Caroverin treatment	treatment takes 5 days, follow up examination 4 weeks after
to investigate the impact of Caroverin treatment of quality of life	treatment takes 5 days, follow up examination 4 weeks after

Collaborators and Investigators

• Sponsor: Phafag AG
• Investigators: Principal Investigator: Wolfgang Elsaesser, Dr., Landeskrankenhaus Feldkirch

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): August 1, 2015
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Morbus Meniere; Sudden hearing loss; Blast injury; Presbyacusis; Chron. Otitis Media
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 1-09; 2009-018046-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No