NCT00841230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

January 30, 2009

Last Update Submit

August 10, 2009

Conditions

Tinnitus

Keywords

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    3 weeks, 6 weeks

Study Arms (2)

Lactose placebo

PLACEBO COMPARATOR

1x/day

Drug: Lactose placebo

Deanxit

EXPERIMENTAL
Drug: Deanxit

Interventions

DeanxitDRUG

Deanxit 1x/day

Deanxit
Lactose placeboDRUG

Lactose used as placebo

Lactose placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Antwerp, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Tinnitus

Interventions

flupentixol, melitracen drug combination

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Meeus, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 11, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

BE(1)