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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Il-Yang Pharm. Co., Ltd.
• Treatments: Mirabegron; Oxybutynin

Criteria

Inclusion Criteria:

• Subject has been diagnosed with overactive bladder (incontinence, frequent urination, enuresis) according to the International Children's Continence Society (ICCS)

• Ages between 5 and 18

• Subject has baseline body weight of 11 kg

• Subject has symptoms of overactive bladder even after two weeks of wash-out period

• Subject is able to follow and record information on 48 hours voiding diary during the trial period

• Subject is able to swallow oral pill form of Hibero (Mirabegron) or Ditropan (Oxybutynin Chloride)

• Subject has agreed to be followed up for 10 weeks, including the safety monitoring period

• Subject, who is sexually active, has agreed to use at least one effective contraceptive method throughout the trial period, including the safety monitoring period.

• The baseline hCG urine test should be negative for female subject to be enrolled in the trial.

• Subject has normal ECG and vital signs (blood pressure, pulse) at the time of screening

Exclusion Criteria:

• Subject has been diagnosed with congenital lower urinary tract dysfunction, neurogenic detrusor overactivity, or secondary detrusor overactivity.

• Subject is currently in treatment for psychiatric disorder (i.e. depression, attention-deficit/ hyperactivity disorder, bipolar disorder, schizophrenia)

• Subject uses clean intermittent catheterization (CIC) for neurogenic detrusor overactivity or due to urologic dysfunction.

• At the time of baseline (randomization), the urine test returns positive for urinary tract infection (UTI).

• Subject has a history of operation on the lower urinary tract or due to vesicoureteral reflux.

• Subject is unable to swallow the pill form of Hibero (Mirabegron) or Ditropan (Oxybutynin Chloride).

• Subject is unwilling or unable to follow the directions from the clinical trial team.

• Subject has been exposed to either mirabegron or any form of antimuscarinic before the study enrollment (as for antimuscarinic, a subject may be enrolled after two weeks of washout period).

• Subject has anaphylactic reactions either to mirabegron or ditropan

• Subject has moderate to severe hepatic or renal impairment subjects.

• Subject has been prescribed with strong CYP3A4 inhibitors and have moderate-severe hepatic or renal impairment

• Subject with the following conditions: lower urinary tract obstruction, urinary retention, glaucoma, narrow tunnel vision, paralytic intestinal obstruction, moderate-severe cardiovascular impaired, ulcerative colitis

• As both investigational products contain lactose, the administration of the products is prohibited for those with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Subject with uncontrolled hypertension, which is defined as systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.

• Subject has previous history or currently in treatment for any type of cardiovascular disorders.