Back to results

Caroverin and Inner Ear Diseases

Primary Purpose

Tinnitus

Status

Suspended

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Caroverin

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Morbus Meniere, Sudden hearing loss, Blast injury, Presbyacusis, Chron. Otitis Media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Landeskrankenhaus Feldkirch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caroverin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.

Secondary Outcome Measures

to investigate the time from the start of treatment to an improvement in tinnitus

to investigate the efficacy of Caroverin depending the origin of tinnitus

to investigate the safety of Caroverin treatment

to investigate the impact of Caroverin treatment of quality of life

Full Information

NCT ID

NCT01174979

First Posted

August 2, 2010

Last Updated

August 4, 2015

Sponsor

Phafag AG

1. Study Identification

Unique Protocol Identification Number

NCT01174979

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Suspended

Why Stopped

due to less patient the study was suspended

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phafag AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

Keywords

Morbus Meniere, Sudden hearing loss, Blast injury, Presbyacusis, Chron. Otitis Media

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Caroverin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Caroverin

Intervention Description

treatment with eardrops 2 times for 48 hours

Primary Outcome Measure Information:

Title

to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.

Time Frame