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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
234
30 mL, TID
30 mL, TID
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period
Time frame: 3 months
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.
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.
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.
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Time frame: 6 months after the first dose