Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

Phase 1

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Meditoxin; Drug: Botox

• Registration Number: NCT03371342
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-11
• Study Start: 2017-12-13
• Study First Posted: 2017-12-13
• Primary Completion: 2018-05-31
• Study Completion: 2018-09-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDITOXIN	Meditoxin	-
BOTOX	Botox	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in adverse events of MEDITOXIN at 12 week	baseline, week 12 follow up visits	safety profiles

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the daily average number of episodes of urinary incontinence	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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of