NCT06765993

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of Isosorbide Oral Solution in the Treatment of Meniere's Disease

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Lunan Better Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniere´s Disease

Interventions

Type	Name	Description
DRUG	Isosorbide oral solution	30 mL, TID
DRUG	Placebo	30 mL, TID

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-06-30
• Completion: 2027-12-30
• First posted: 2025-01-09
• Last updated: 2025-01-09