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NCT03371342 Clinical Trial

Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03371342
Other study ID # MT01-KR17OAB101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 13, 2017
Est. completion date September 5, 2018

Study information
Verified date March 2019
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 5, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Meditoxin
Meditoxin (Botulinum toxin type A)
• Botox
Botox(Botulinum toxin type A)

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in adverse events of MEDITOXIN at 12 week safety profiles baseline, week 12 follow up visits
Secondary 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. baseline, week 12 follow up visits
See also
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Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
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Completed NCT00910845 - Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3