The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril...
Date First Received: January 30, 2009
Last Updated: August 10, 2009
Verified by: University Hospital, Antwerp, August 2009
Clinical Trial Phase: Phase 4 | Start Date: February 2009
Overall Status: Completed
Estimated Enrollment: 50
Brief Summary
Official Title: “Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: July 2009
Intervention(s) in this Clinical Trial
- Drug: Deanxit
- Deanxit 1x/day
- Drug: Lactose placebo
- Lactose used as placebo
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: Lactose placebo
- 1x/day
- Experimental: Deanxit
Outcome Measures for this Clinical Trial
Primary Measures
- Visual Analogue Scale
- Time Frame: 3 weeks, 6 weeks
Safety Issue?: No
- Time Frame: 3 weeks, 6 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Antwerp
Overall Clinical Trial Officials and Contacts
Olivier Meeus, MD Principal Investigator University Hospital, Antwerp
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00841230
Study ID Number: 8/46/260
ClinicalTrials.gov Identifier: NCT00841230
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Clinical Trials Authorship and Review
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