Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

March 25, 2019 updated by: Medy-Tox

A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder

To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female aged more than 20 years
  • Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening

Exclusion Criteria:

- Patient not appropriate for participating in this study according to the investigator's opinion

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: MEDITOXIN
Drug: Meditoxin
Meditoxin (Botulinum toxin type A)
Active Comparator: BOTOX
Drug: Botox
Botox(Botulinum toxin type A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in adverse events of MEDITOXIN at 12 week
Time Frame: baseline, week 12 follow up visits
safety profiles
baseline, week 12 follow up visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the daily average number of episodes of urinary incontinence
Time Frame: baseline, week 12 follow up visits
Urinary incontinence recorded by the participants in a bladder diary during the 3 consecutive days prior to the study visit.
baseline, week 12 follow up visits

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)

December 13, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

September 5, 2018

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT01-KR17OAB101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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