Back to resultsDeanxit and Rivotril in Tinnitus Patients
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Deanxit
Lactose placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus
Eligibility 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
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Lactose placebo
Deanxit
Arm Description
1x/day
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT00841230
First Posted
January 30, 2009
Last Updated
August 10, 2009
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00841230
Brief Title
Deanxit and Rivotril in Tinnitus Patients
Official Title
Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactose placebo
Arm Type
Placebo Comparator
Arm Description
1x/day
Arm Title
Deanxit
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Deanxit
Intervention Description
Deanxit 1x/day
Intervention Type
Drug
Intervention Name(s)
Lactose placebo
Intervention Description
Lactose used as placebo
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
3 weeks, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Meeus, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Deanxit and Rivotril in Tinnitus Patients
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