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)
NCT ID: NCT06181591
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
44 participants
INTERVENTIONAL
2024-04-01
2025-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hibero SR (Mirabegron) 50 mg
Subjects aged between 5 and 18 years will receive a daily dose of IP orally starting from baseline to week 8.
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.
Ditropan (Oxybutynin Chloride) 10 mg
Subjects aged between 5 and 18 years will receive a daily dose of active comparator orally starting from baseline to week 8.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
18 Years
ALL
No
Sponsors
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Il-Yang Pharm. Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Kwanjin Park
Professor
Principal Investigators
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Kwanjin Park, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital (Department of Urology)
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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H-2310-153-1481
Identifier Type: -
Identifier Source: org_study_id
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