Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder

Medytox

Status and phase: Unknown; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Neuronox; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04113941

MT01-KR17OAB302

Details and patient eligibility

About

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

Enrollment: 216 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

Neuronox®

Experimental group

Description:

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

Treatment:

Drug: Neuronox

Placebo

Placebo Comparator group

Description:

Normal saline, same volume with Experimental arm

Treatment:

Drug: Placebo