Caroverin and Inner Ear Diseases

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01174979
• Other study ID #: 1-09
• Secondary ID: 2009-018046-38
• Status: Suspended
• Phase: Phase 3
• First received: August 2, 2010
• Last updated: August 4, 2015
• Start date: January 2011

Study information

• Verified date: August 2015
• Source: Phafag AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im GesundheitswesenAustria: Ethics Commitee Vorarlberg
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 170
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Caroverin
treatment with eardrops 2 times for 48 hours

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch	Vorarlberg

Sponsors (1)

Lead Sponsor	Collaborator
Phafag AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to investigate the time from the start of treatment to an improvement in tinnitus		treatment takes 5 days, follow up examination 4 weeks after	No
Secondary	to investigate the efficacy of Caroverin depending the origin of tinnitus		treatment takes 5 days, follow up examination 4 weeks after	No
Secondary	to investigate the safety of Caroverin treatment		treatment takes 5 days, follow up examination 4 weeks after	Yes
Secondary	to investigate the impact of Caroverin treatment of quality of life		treatment takes 5 days, follow up examination 4 weeks after	Yes