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

Phafag AG1 site in 1 country170 target enrollmentJanuary 2011

ConditionsTinnitus

InterventionsCaroverin

DrugsCaroverin

Overview

Phase: Phase 3
Intervention: Caroverin
Conditions: Tinnitus
Sponsor: Phafag AG
Enrollment: 170
Locations: 1
Primary Endpoint: to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.
Status: Suspended
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

August 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Phafag AG

Responsible Party

Sponsor

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

Arms & Interventions

Caroverin

Intervention: Caroverin

Placebo

Intervention: Caroverin

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)