Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease (NCT06765993) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease
234 participantsStarted 2024-12-30
Plain-language 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 â…¡ and approximately 162 subjects in phase â…¢. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase â…¡ and phase â…¢ were 1:1 and 2:1, respectively.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
✕. 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.
✕
What they're measuring
1
The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period