Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder

Phase 3

• Conditions: Overactive Bladder
• Interventions: Drug: Placebo; Drug: Neuronox

• Registration Number: NCT04113941
• Lead Sponsor: Medy-Tox

Brief Summary

This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study Start: 2019-08-23
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Primary Completion: 2020-04-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Male and female subjects aged above 20
• Patient with overactive bladder symptoms lasting at least 6 months

Exclusion Criteria

• Patient with a history of surgery or a disease that may affect bladder function.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline, same volume with Experimental arm
Neuronox®	Neuronox	Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites

Primary Outcome Measures

Name	Time	Method
The change in the daily average UI (Urinary Incontinence) episodes	12 weeks

Trial Locations

Locations (1)

Konkuk University Hospital; 🇰🇷 Seoul, Korea, Republic of