Overview

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)

Status:
Not yet recruiting

Trial end date:
2025-04-15

Target enrollment:

Participant gender:

Summary

The purpose of this study was to assess the efficacy of Hibero (Mirabegron) versus active control (Ditropan: Oxybutynin Chloride) in the treatment of pediatric subjects (5 to < 18 years of age) with overactive bladder. This study will further evaluate the safety of mirabegron in pediatric subjects with OAB after multiple dose adminstration.

Phase:

Phase 2

Details

Lead Sponsor:

Seoul National University Hospital

Collaborator:

Il-Yang Pharm. Co., Ltd.

Treatments:

Mirabegron
Oxybutynin