A Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 1, 2025

Study Completion Date

April 15, 2025

Conditions
Overactive Bladder
Interventions
DRUG

Mirabegron 50 MG

Mirabegron (IP: Hibero) is a beta-3 adrenergic agonist used to treat overactive bladder (OAB) and neurogenic detrusor overactivity (NDO). It is used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence. Through a 8 weeks clinical trial, it aims to evaluate the efficacy and safety of Hibero (Mirabegron), especially in maximum voided volume.

DRUG

Oxybutynin Chloride 5 MG

Oxybutynin has been used to treat overactive bladder (OAB). The subject will take 5 mg of Ditropan (Oxybutynin Chloride) twice a day, in total of 10 mg for 8 weeks.

Trial Locations (1)

Unknown

Seoul National University Hospital, Seoul

All Listed Sponsors
collaborator

Il-Yang Pharm. Co., Ltd.

INDUSTRY

lead

Seoul National University Hospital

OTHER