Deanxit and Rivotril in Tinnitus Patients
Information source: University Hospital, Antwerp
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinnitus
Intervention: Deanxit (Drug); Lactose placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Antwerp Official(s) and/or principal investigator(s): Olivier Meeus, MD, Principal Investigator, Affiliation: University Hospital, Antwerp
Summary
The purpose of this study is to investigate whether increased tinnitus reduction can be
obtained with Deanxit in patients already receiving Rivotril.
Clinical Details
Official title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Visual Analogue Scale
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Antwerp University Hospital, Antwerp 2650, Belgium
Additional Information
Starting date: February 2009
Last updated: August 10, 2009
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