Efficacy and Safety of Isosorbide Oral Solution in Patients With 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.

NCT Number	NCT06765993
Lead Sponsor	Lunan Better Pharmaceutical Co., LTD.
Conditions	Meniere´s Disease
Enrollment	234 participants
Start Date	2024-12-30
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-01-09