Deanxit and Rivotril in Tinnitus Patients

Tinnitus Clinical Trial

Official title:

Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841230
• Other study ID #: 8/46/260
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2009
• Last updated: August 10, 2009
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Deanxit
Deanxit 1x/day
• Lactose placebo
Lactose used as placebo

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale		3 weeks, 6 weeks	No