Vestibular Disorder PreservationNCT05355610
Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease
A study testing Gentamicin and Dexamethasone in people with Vestibular Disorder Preservation, run by Combined Military Hospital Quetta at 1 site in Pakistan.
Trial summary
Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. At the same time intratympanic dexamethasone will be used to rescue hearing Read more about this study
- Who is it for?
- Ages 24 to 65 years
- Conditions the study is for
- Vestibular Disorder Preservation
- What is being tested?
- Gentamicin and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 30 May 2022
- Phase
- Interventional
- 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 24 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of unilateral Meniere's disease with severe vestibular symptoms
Who cannot join
- Bilateral disease, operated cases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Quetta
Quetta, Balochistan, 87300
Zeeshan Ayub, FCPS, +923215233648
Azeema Ahmed, FCPS, +923325222335, azeemazeeshan1980@gmail.com
About this study
Official title: Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease
Intractable symptoms of Meniere's disease will be treated with intratympanic steroids.
At the same time intratympanic dexamethasone will be used to rescue hearing
Read the detailed description
For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index.
At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold
- Conditions
- Vestibular Disorder Preservation
- Being tested
- Gentamicin, Dexamethasone
- Keywords
- dexamethasone, gentamicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentamicinDrug
Also called Intratympanic gentamicin
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
DexamethasoneDrug
Also called Intratympanic dexamethasone
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
| Study group | Role | What they receive |
|---|---|---|
| Vestibular severity index improvement | Experimental | Improvement in vestibular symptoms with intratympanic gentamicin Receives: Drug: Gentamicin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular Rehabilitation
Improvement in vestibular severity index
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Apr 2021
- Primary completion22 Apr 2022
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Disorder PreservationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Quetta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zeeshan Ayub, Combined Military Hospital Quetta
- Investigators
- Zeeshan Ayub, FCPS, Principal investigator, Combined Military Hospital QuettaZeeshan Ayub, FCPS, Study chair, Combined Military Hospital Quetta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355610
- Sponsor's protocol ID
- File No: CMH QTA-IRB/043
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease
- ClinicalTrials.gov ID
- NCT05355610
- Acronym / sponsor ID
- File No: CMH QTA-IRB/043
- Conditions
- Vestibular Disorder Preservation
- Keywords
- dexamethasone, gentamicin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Combined Military Hospital QuettaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- 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.
Intractable symptoms of Meniere's disease will be treated with intratympanic steroids.
At the same time intratympanic dexamethasone will be used to rescue hearing
Detailed description
For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index.
At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart
| Arm | Type | Receives |
|---|---|---|
| Vestibular severity index improvement | Experimental | Drug: Gentamicin, Drug: DexamethasoneImprovement in vestibular symptoms with intratympanic gentamicin |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of unilateral Meniere's disease with severe vestibular symptoms
Key exclusion criteria (1 listed)
- Bilateral disease, operated cases
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 |
|---|---|---|
| GentamicinAlso: Intratympanic gentamicinIntratympanic gentamicin and dexamethasone administered in two doses one week apart | Drug | Vestibular severity index improvement |
| DexamethasoneAlso: Intratympanic dexamethasoneIntratympanic gentamicin and dexamethasone administered in two doses one week apart | Drug | Vestibular severity index improvement |
Primary outcome
Vestibular Rehabilitation
Time frame: Three months
Improvement in vestibular severity index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Related trials for Vestibular Disorder Preservation
Active, not recruitingObservational study
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
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.
Zeeshan Ayub, FCPS principal investigator
Combined Military Hospital Quetta
Zeeshan Ayub, FCPS study chair
Combined Military Hospital Quetta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentamicin and Dexamethasone in people with Vestibular Disorder Preservation, run by Combined Military Hospital Quetta at 1 site in Pakistan.
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 1 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: status not confirmed, as of the sponsor's last update on 2 May 2022. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeeshan Ayub, FCPS (+923215233648, zeeshanent@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular Rehabilitation (time frame: Three months). 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 2 May 2022.