Meniere's DiseasePhase 4NCT00160238
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
A Phase 4 study testing Betahistine 24 mg bid (Betaserc) in people with Meniere's Disease, run by Solvay Pharmaceuticals at 1 site in France.
Trial summary
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- Betahistine 24 mg bid (Betaserc)
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2003to not given
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia
Who cannot join
- Other peripheral vestibular disease than Menière's disease
- Central vestibular disease
- Neurological disease
- Contraindication to betahistine
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.
- Conditions
- Meniere's Disease
- Being tested
- Betahistine 24 mg bid (Betaserc)
- Keywords
- Meniere's disease, Vestibular neurotomy
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betahistine 24 mg bid (Betaserc)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia
Secondary outcomes (1)
Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160238
- Sponsor's protocol ID
- S108.4.102
- Status last verified
- Dec 2006
- First submitted
- 9 Sep 2005
- Last updated
- 22 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease
- ClinicalTrials.gov ID
- NCT00160238
- Acronym / sponsor ID
- S108.4.102
- Conditions
- Meniere's Disease
- Keywords
- Meniere's disease, Vestibular neurotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- First posted
- 12 Sep 2005 (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.
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia
Key exclusion criteria (5 listed)
- Other peripheral vestibular disease than Menière's disease
- Central vestibular disease
- Neurological disease
- Contraindication to betahistine
- Pregnant or lactating women
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 |
|---|---|---|
| Betahistine 24 mg bid (Betaserc) | Drug | – |
Primary outcome
Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia
1 secondary outcome
Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women
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 22 Dec 2006.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
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 Betahistine 24 mg bid (Betaserc) in people with Meniere's Disease, run by Solvay Pharmaceuticals at 1 site in France.
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 1 inclusion and 5 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 22 Dec 2006. 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 France. 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. 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?
Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia. 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 22 Dec 2006.