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

July 27, 2020 updated by: Medy-Tox

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuronox®
Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites
Drug: Neuronox
intradetrusor injection
Other Names:
  • Meditoxin
Placebo Comparator: Placebo
Normal saline, same volume with Experimental arm
Drug: Placebo
intradetrusor injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in the daily average UI (Urinary Incontinence) episodes
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

April 15, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT01-KR17OAB302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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