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

Overactive Bladder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04113941
• Other study ID #: MT01-KR17OAB302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 23, 2019
• Est. completion date: August 2021

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: August 2021
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Neuronox
intradetrusor injection
• Placebo
intradetrusor injection

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the daily average UI (Urinary Incontinence) episodes		12 weeks