Deanxit and Rivotril in Tinnitus Patients

This study has been completed.

First Received on January 30, 2009. Last Updated on August 10, 2009 History of Changes

Sponsor:	University Hospital, Antwerp
Information provided by:	University Hospital, Antwerp
ClinicalTrials.gov Identifier:	NCT00841230

Purpose

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

Condition	Intervention	Phase
Tinnitus	Drug: Deanxit Drug: Lactose placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

Drug Information available for: Lactose Clonazepam

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:

Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Lactose placebo 1x/day	Drug: Lactose placebo Lactose used as placebo
Experimental: Deanxit	Drug: Deanxit Deanxit 1x/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841230

Locations

Belgium
Antwerp University Hospital
Antwerp, Belgium, 2650

Sponsors and Collaborators

University Hospital, Antwerp

Investigators

Principal Investigator:

Olivier Meeus, MD

University Hospital, Antwerp

More Information

No publications provided

Responsible Party:	Prof Dr P H Van de Heyning, Antwerp University Hospital
ClinicalTrials.gov Identifier:	NCT00841230 History of Changes
Other Study ID Numbers:	8/46/260
Study First Received:	January 30, 2009
Last Updated:	August 10, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:

Tinnitus

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clonazepam

Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012