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.
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.
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 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);
Parallel
Isosorbide oral solution
Drug30 mL, TID
Placebo
Drug30 mL, TID
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period
The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 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.
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.
Patient-reported outcomes (PRO) during the treatment period were assessed using the Dizziness Handicap Inventory (DHI).
The incidence and level of adverse events (AEs), serious adverse events (SAEs), abnormal laboratory test indicators, etc.
Change in tinnitus severity from baseline at 6 months after first dosing.
The change from baseline in the number of attacks due to Meniere's disease at 12 months after the first dose.
The change in hearing compared to baseline at 12 months after 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 7 to 12 months after the first administration of the drug.
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