TinnitusPhase 4NCT00841230
Deanxit and Rivotril in Tinnitus Patients
A Phase 4 study testing Deanxit in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Deanxit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2009to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- intake Rivotril 1mg/d
- patient 'able to cooperate'
- patient able to fill in TQ en VAS
- No pontine angle pathology on MRI
Who cannot join
- pulsatile tinnitus
- pregnancy or breast feeding
- contra-indications Deanxit
- recovery myocard infarct
- conduction disorder His
- untreated glaucoma
Show all 11Show fewer
- MAO inhibitors: 15d stop
- otosclerosis
- middle ear pathologies
- Ménière
- somatic tinnitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.
- Conditions
- Tinnitus
- Being tested
- Deanxit, Lactose placebo
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeanxitDrug
Deanxit 1x/day
Lactose placeboDrug
Lactose used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactose placebo | Placebo comparator | 1x/day Receives: Drug: Lactose placebo |
| Deanxit | Experimental | Not described Receives: Drug: Deanxit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Meeus, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841230
- Sponsor's protocol ID
- 8/46/260
- Status last verified
- Aug 2009
- First submitted
- 30 Jan 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
- ClinicalTrials.gov ID
- NCT00841230
- Acronym / sponsor ID
- 8/46/260
- Conditions
- Tinnitus
- Keywords
- Tinnitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose placebo | Placebo comparator | Drug: Lactose placebo1x/day |
| Deanxit | Experimental | Drug: Deanxit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- pure tone, narrow band noise or polyphonic tinnitus
- unilateral or bilateral tinnitus
- VAS ≥ 4
Key exclusion criteria (11 listed)
- pulsatile tinnitus
- pregnancy or breast feeding
- contra-indications Deanxit
- recovery myocard infarct
- conduction disorder His
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeanxitDeanxit 1x/day | Drug | Deanxit |
| Lactose placeboLactose used as placebo | Drug | Lactose placebo |
Primary outcome
Visual Analogue Scale
Time frame: 3 weeks, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Meeus, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deanxit in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 3 weeks, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.