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Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03371342
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 27, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Meditoxin Drug: Botox Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MEDITOXIN Drug: Meditoxin
Meditoxin (Botulinum toxin type A)

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

Primary Outcome Measures :
  1. Change from baseline in adverse events of MEDITOXIN at 12 week [ Time Frame: baseline, week 12 follow up visits ]
    safety profiles

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03371342

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
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Responsible Party: Medy-Tox Identifier: NCT03371342    
Other Study ID Numbers: MT01-KR17OAB101
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents