Back to resultsTreatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meditoxin
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MEDITOXIN
BOTOX
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in adverse events of MEDITOXIN at 12 week
safety profiles
Secondary Outcome Measures
Change from baseline in the daily average number of episodes of urinary incontinence
Urinary incontinence recorded by the participants in a bladder diary during the 3 consecutive days prior to the study visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03371342
Brief Title
Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)
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
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX
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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDITOXIN
Arm Type
Experimental
Arm Title
BOTOX
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Description
Meditoxin (Botulinum toxin type A)
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
Botox(Botulinum toxin type A)
Primary Outcome Measure Information:
Title
Change from baseline in adverse events of MEDITOXIN at 12 week
Description
safety profiles
Time Frame
baseline, week 12 follow up visits
Secondary Outcome Measure Information:
Title
Change from baseline in the daily average number of episodes of urinary incontinence
Description
Urinary incontinence recorded by the participants in a bladder diary during the 3 consecutive days prior to the study visit.
Time Frame
baseline, week 12 follow up visits
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder
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