Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease

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. 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.

Timeline

Start

2024-12-30

Primary completion

2027-06-30

Completion

2027-12-30

Drugs

Indications