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)

NCT06181591 | Not Yet Recruiting Phase 2

• 1 other identifier: H-2310-153-1481
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years

  Subject will complete 2-days voiding diary (48 hours) before each visit. Maximum voided volume will be derived from the 2-day voiding diary.

  Baseline, Week 4, Week 8

Secondary Outcomes (4)

• Total frequency of urinary incontinence

  Baseline, Week 4, Week 8

• Total frequency of urinary urgency

  Baseline, Week 4, Week 8

• Dysfunctional Voiding Symptoms Score, DVSS

  Baseline, Week 4, Week 8

• Investigational Product (IP) Adherence and Accountability

  Week 4, Week 8

Other Outcomes (5)

• Patient Reported Treatment Emergent Adverse Events

  Week 4, Week 8, Week 10 (Safety Monitoring TC)

• Adverse Events of Special Interests (AESI)

  Week 4, Week 8, Week 10 (Safety Monitoring TC)

• Cardiovascular safety profile: ECG QT Interval

  Screening, Baseline, Week 4, Week 8

Study Arms (2)

Hibero SR (Mirabegron) 50 mg

EXPERIMENTAL

Subjects aged between 5 and 18 years will receive a daily dose of IP orally starting from baseline to week 8.

Drug: Mirabegron 50 MG

Ditropan (Oxybutynin Chloride) 10 mg

ACTIVE COMPARATOR

Subjects aged between 5 and 18 years will receive a daily dose of active comparator orally starting from baseline to week 8.

Drug: Oxybutynin Chloride 5 MG

Interventions

Mirabegron 50 MG DRUG

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.

Also known as: Hibero, Myrbetriq, Betigma

Hibero SR (Mirabegron) 50 mg

Oxybutynin Chloride 5 MG DRUG

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.

Also known as: Ditropan

Ditropan (Oxybutynin Chloride) 10 mg

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Il-Yang Pharm. Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kwanjin Park, MD/PhD

  Seoul National University Hospital (Department of Urology)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwanjin Park, MD/PhD

CONTACT

+82-2072-0695; urodori9@snu.ac.kr

Louis Kim, BSPH

CONTACT

+82-10-4201-0636; kim.hyunkyu11@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 26, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)