Deanxit and Rivotril in Tinnitus Patients

The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Completed

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antwerp University Hospital

Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pure tone, narrow band noise or polyphonic tinnitus
unilateral or bilateral tinnitus
VAS ≥ 4

cochleair origin tinnitus
tinnitus present 3 months or more
age 18y or more
intake Rivotril 1mg/d
patient 'able to cooperate'
patient able to fill in TQ en VAS
No pontine angle pathology on MRI

Exclusion criteria

pulsatile tinnitus
pregnancy or breast feeding
contra-indications Deanxit
recovery myocard infarct
conduction disorder His
untreated glaucoma
MAO inhibitors: 15d stop
otosclerosis
middle ear pathologies
Ménière
somatic tinnitus

Treatment and study plan

Deanxit

Drug

Deanxit 1x/day

Lactose placebo

Drug

Lactose used as placebo

Primary outcomes

Visual Analogue Scale

Time frame: 3 weeks, 6 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 11, 2009
Registry last updated: Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed