Meniere´s DiseasePhase 2/3MDNCT06765993
Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease
A Phase 2/3 study testing Isosorbide oral solution in people with Meniere´s Disease, run by Lunan Better Pharmaceutical Co., LTD..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. 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?
- Isosorbide oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Male or female aged ≥18 and ≤65 years old.
- Patients with unilateral Meniere's disease who meet the diagnostic criteria for Meniere's disease in the Guidelines for the Diagnosis and Treatment of Meniere's Disease (2017).
- At least 3 episodes of vertigo caused by Meniere's disease within 6 months before enrollment.
- Those who understand and voluntarily sign the informed consent.
Who cannot join
- Patients who have had previous ear surgery for Meniere's disease.
- People who suffer from vertigo caused by organic lesions of the external, middle or inner ear.
- Patients with diseases that the investigators believe may limit the subjects' participation in this trial:
- patients with acute intracranial hematoma;
- patients with hypokalemia (serum potassium < lower limit of normal) or severe dehydration (needing infusion, or hospitalization, or life-threatening, requiring emergency treatment);
- patients with acute pulmonary edema;
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- patients with hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg during the screening period);
- patients with severe cardiovascular and cerebrovascular diseases: such as New York Heart Association grade III or IV heart failure, myocardial infarction or unstable angina pectoris within the last 6 months, severe heart failure, progressive multifocal leukoencephalopathy, hypertension that is difficult to control with drugs (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg), etc.;
- patients with major diseases of other important organs that affect their participation in this study.
- Patients who need to use diuretics other than trial drugs for a long time after enrollment.
- Patients with any of the following conditions are known or found in laboratory tests:
- serum creatinine (Cr) level is not within the normal range;
- human immunodeficiency virus (HIV) test is positive or has acquired immunodeficiency syndrome (AIDS);
- active syphilis infection (positive Treponema pallidum antibody and positive non-specific syphilis antibody);
- active hepatitis, hepatitis B: HBsAg and/or HBcAb are positive and HBV-DNA > 500 IU/mL or the lower limit of detection of the research center [only when the lower limit of detection of the research center is higher than 500 IU/mL]; hepatitis C: HCV antibody is positive and HCV-RNA is positive or greater than the upper limit of normal value.
- Patients with known or suspected history of allergy to the investigational drug (isosorbide) and its excipients (sorbitol, lactic acid, saccharin sodium, propylparaben, butylparaben, orange flavor).
- Those with a history of drug abuse or alcoholism within 6 months before enrollment.
- Patients who have taken any prohibited drugs specified in this protocol for more than 1 week within 4 weeks before the first administration, including but not limited to vestibular suppressants (including antihistamines - promethazine, diphenhydramine, chlorpheniramine, etc., benzodiazepines - diazepam, lorazepam, clonazepam, etc., anticholinergics - scopolamine, atropine, glycopyrrolate, etc., and antidopamines - prochlorperazine, droperidol, etc.), betahistine, diuretics (including thiazide diuretics - hydrochlorothiazide, chlorthalidone, indapamide, indapamide sustained-release tablets, etc., loop diuretics - furosemide, torsemide, etc., potassium-sparing diuretics - amiloride, triamterene, etc.), glucocorticoids (including prednisone, methylprednisolone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, etc.).
- Those who received intratympanic injection of gentamicin within the last year.
- Patients who have received any other clinical trial drugs/devices within 30 days before the first dose.
- Pregnant or lactating women, female patients or male patients' partners who plan to become pregnant during the study period and within 6 months after the last dose, and those who are unwilling to use a medically recognized effective contraceptive method (such as intrauterine contraceptive device or condom) during the trial.
- Those who are judged by the researchers to be unsuitable for inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of Isosorbide Oral Solution in the Treatment of Meniere's Disease
The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.
- Conditions
- Meniere´s Disease
- Being tested
- Isosorbide oral solution, Placebo
- Keywords
- Meniere´s disease, Attack, Hearing loss, Tinnitus, Isosorbide
- Medical subject headings
- Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide oral solutionDrug
30 mL, TID
PlaceboDrug
30 mL, TID
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Isosorbide oral solution |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period
Measured: 3 months
Secondary outcomes (7)
The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 6 months after the first administration.
Measured: 6 months after the first administration
The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 4-6 months after the first administration.
Measured: 4-6 months after the first administration
The changes in hearing from baseline 6 months after the first dose.
The assessment was made by subtracting the average hearing threshold of the worst pure tone audiometry test in the 6 months before treatment from the average hearing threshold of the worst pure tone audiometry test in the period 1 to 6 months after the first administration of the drug.
Measured: 6 months after first dose
Patient-reported outcomes (PRO) during the treatment period were assessed using the Dizziness Handicap Inventory (DHI).
Measured: 3 months after the first dose
Patient-reported outcomes (PRO) during the treatment period were assessed using the Tinnitus Handicap Inventory (THI).
Measured: 3 months after the first dose
Patient-reported outcomes (PRO) were assessed using the Dizziness Handicap Inventory (DHI) at 6 months after the first dose.
Measured: 6 months after the first dose
Patient-reported outcomes (PRO) were assessed using the Tinnitus Handicap Inventory (THI) at 6 months after the first dose.
Measured: 6 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765993
- Sponsor's protocol ID
- BT-YSLC-001
- Acronym
- MD
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to publish the findings in ICMJE journals.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of Isosorbide Oral Solution in the Treatment of Meniere's Disease
- ClinicalTrials.gov ID
- NCT06765993
- Acronym / sponsor ID
- MD / BT-YSLC-001
- Conditions
- Meniere´s Disease
- Keywords
- Meniere´s disease, Attack, Hearing loss, Tinnitus, Isosorbide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Isosorbide oral solution |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged ≥18 and ≤65 years old.
- Patients with unilateral Meniere's disease who meet the diagnostic criteria for Meniere's disease in the Guidelines for the Diagnosis and Treatment of Meniere's Disease (2017).
- At least 3 episodes of vertigo caused by Meniere's disease within 6 months before enrollment.
- Those who understand and voluntarily sign the informed consent.
Key exclusion criteria (22 listed)
- Patients who have had previous ear surgery for Meniere's disease.
- People who suffer from vertigo caused by organic lesions of the external, middle or inner ear.
- Patients with diseases that the investigators believe may limit the subjects' participation in this trial:
- Patients who need to use diuretics other than trial drugs for a long time after enrollment.
- Patients with any of the following conditions are known or found in laboratory tests:
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 |
|---|---|---|
| Isosorbide oral solution30 mL, TID | Drug | Experimental group |
| Placebo30 mL, TID | Drug | Control group |
Primary outcome
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period
Time frame: 3 months
7 secondary outcomes
The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 6 months after the first administration.
Time frame: 6 months after the first administration
The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 4-6 months after the first administration.
Time frame: 4-6 months after the first administration
The changes in hearing from baseline 6 months after the first dose.
Time frame: 6 months after first dose
Patient-reported outcomes (PRO) during the treatment period were assessed using the Dizziness Handicap Inventory (DHI).
Time frame: 3 months after the first dose
Patient-reported outcomes (PRO) during the treatment period were assessed using the Tinnitus Handicap Inventory (THI).
Time frame: 3 months after the first dose
Patient-reported outcomes (PRO) were assessed using the Dizziness Handicap Inventory (DHI) at 6 months after the first dose.
Time frame: 6 months after the first dose
Patient-reported outcomes (PRO) were assessed using the Tinnitus Handicap Inventory (THI) at 6 months after the first dose.
Time frame: 6 months after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No. There are no plans to publish the findings in ICMJE journals.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Isosorbide oral solution in people with Meniere´s Disease, run by Lunan Better Pharmaceutical Co., LTD..
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 4 inclusion and 22 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: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijia Kong, PhD (027-85726685, entwjkong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period (time frame: 3 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 9 Jan 2025.