Back to resultsClinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neuronox
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged above 20
- Patient with overactive bladder symptoms lasting at least 6 months
Exclusion Criteria:
- Patient with a history of surgery or a disease that may affect bladder function.
Sites / Locations
- Konkuk University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Neuronox®
Placebo
Arm Description
Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites
Normal saline, same volume with Experimental arm
Outcomes
Primary Outcome Measures
The change in the daily average UI (Urinary Incontinence) episodes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04113941
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Official Title
A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuronox®
Arm Type
Experimental
Arm Description
Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline, same volume with Experimental arm
Intervention Type
Drug
Intervention Name(s)
Neuronox
Other Intervention Name(s)
Meditoxin
Intervention Description
intradetrusor injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intradetrusor injection
Primary Outcome Measure Information:
Title
The change in the daily average UI (Urinary Incontinence) episodes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects aged above 20
Patient with overactive bladder symptoms lasting at least 6 months
Exclusion Criteria:
Patient with a history of surgery or a disease that may affect bladder function.
Facility Information:
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
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