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OpenTrials
Completed

NCT Number: NCT03371342

Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

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

Completed

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditoxin

Drug

Meditoxin (Botulinum toxin type A)

Botox

Drug

Botox(Botulinum toxin type A)

Primary outcomes

  1. Change from baseline in adverse events of MEDITOXIN at 12 week

    Time frame: baseline, week 12 follow up visits

    safety profiles

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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