NCT04113941

Brief Summary

This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 1, 2019

Last Update Submit

July 27, 2020

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • The change in the daily average UI (Urinary Incontinence) episodes

    12 weeks

Study Arms (2)

Neuronox®

EXPERIMENTAL

Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites

Drug: Neuronox

Placebo

PLACEBO COMPARATOR

Normal saline, same volume with Experimental arm

Drug: Placebo

Interventions

NeuronoxDRUG

intradetrusor injection

Also known as: Meditoxin
Neuronox®
PlaceboDRUG

intradetrusor injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects aged above 20
  • Patient with overactive bladder symptoms lasting at least 6 months

You may not qualify if:

  • Patient with a history of surgery or a disease that may affect bladder function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Hospital

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

October 3, 2019

Study Start

August 23, 2019

Primary Completion

April 15, 2020

Study Completion

August 1, 2021

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

KR(1)