Deanxit and Rivotril in Tinnitus Patients | NCT00841230

Studies
Deanxit and Rivotril in Tinnitus Patients

NCT00841230

Sponsor

University Hospital, Antwerp

Status

Completed

Last Update Posted

Aug 11, 2009Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Tinnitus

Interventions

Deanxit
Lactose placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jan 30, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2009

Last Update Posted Date

Aug 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactose placebo	Placebo Comparator	1x/day	Drug: Lactose placebo
Deanxit	Experimental		Drug: Deanxit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deanxit	Drug	Deanxit 1x/day	Deanxit
Lactose placebo

Measure	Description	Time Frame
Visual Analogue Scale		3 weeks, 6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Meeus, MD	University Hospital, Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Antwerp	Antwerp	2650	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000851	flupentixol, melitracen drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided