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Deanxit and Rivotril in Tinnitus Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00841230
First received: January 30, 2009
Last updated: August 10, 2009
Last verified: August 2009
History of Changes
  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 4

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: 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 May 16, 2013