NCT03371342

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

November 28, 2017

Last Update Submit

March 25, 2019

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in adverse events of MEDITOXIN at 12 week

    safety profiles

    baseline, week 12 follow up visits

Secondary Outcomes (1)

  • Change from baseline in the daily average number of episodes of urinary incontinence

    baseline, week 12 follow up visits

Study Arms (2)

MEDITOXIN

EXPERIMENTAL
Drug: Meditoxin

BOTOX

ACTIVE COMPARATOR
Drug: Botox

Interventions

MeditoxinDRUG

Meditoxin (Botulinum toxin type A)

MEDITOXIN
BotoxDRUG

Botox(Botulinum toxin type A)

BOTOX

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Patient not appropriate for participating in this study according to the investigator's opinion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 13, 2017

Study Start

December 13, 2017

Primary Completion

May 31, 2018

Study Completion

September 5, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

KR(1)