Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Il-Yang Pharm. Co., Ltd.
Conditions:
Overactive Bladder
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
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 ...
Detailed Description
The trial consists of four periods (Screening/ Washout (2 weeks); Baseline; 4 weeks from baseline; 8 weeks from baseline) excluding the safety monitoring period. It is a randomized, open label, parall...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06181591
Start Date
April 1 2024
End Date
April 15 2025
Last Update
March 8 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea