Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03371342

Enrollment

Registered

2017-12-13

Start date

2017-12-13

Completion date

2018-09-05

Last updated

2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Brief summary

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

Interventions

DRUGMeditoxin

Meditoxin (Botulinum toxin type A)

DRUGBotox

Botox(Botulinum toxin type A)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026