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

NCT ID: NCT04113941

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-23

Study Completion Date

2021-08-31

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Neuronox®

Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites

Group Type EXPERIMENTAL

Neuronox

Intervention Type DRUG

intradetrusor injection

Placebo

Normal saline, same volume with Experimental arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intradetrusor injection

Interventions

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Neuronox

intradetrusor injection

Intervention Type DRUG

Placebo

intradetrusor injection

Intervention Type DRUG

Other Intervention Names

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Meditoxin

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Konkuk University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT01-KR17OAB302

Identifier Type: -

Identifier Source: org_study_id

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