Overactive BladderPhase 2NCT06181591
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)
A Phase 2 study testing Mirabegron 50 MG and Oxybutynin Chloride 5 MG in people with Overactive Bladder, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Mirabegron 50 MG and Oxybutynin Chloride 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2024to 15 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control 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)
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.
Read the 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, parallel group, and active control comparator trial. The subject will be assigned either to Hibero (Mirabegron) 50 mg or Ditropan (Oxybutynin Chloride) 10 mg at baseline (randomization). The subject will be asked to take the IP or active comparator by mouth without crushing the pill for 8 weeks, and the frequency of oral administration depends on the prescribed method.
- Conditions
- Overactive Bladder
- Being tested
- Mirabegron 50 MG, Oxybutynin Chloride 5 MG
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Also called Hibero, Myrbetriq, Betigma
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 MGDrug
Also called Ditropan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oxybutynin Chloride 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Week 8
Secondary outcomes (4)
Total frequency of urinary incontinence
Subject will complete 2-days voiding diary (48 hours) before each visit. Total frequency of urinary incontinence will be derived from the 2-day voiding diary.
Measured: Baseline, Week 4, Week 8
Total frequency of urinary urgency
Subject will complete 2-days voiding diary (48 hours) before each visit. Total frequency of urinary urgency will be derived from the 2-day voiding diary.
Measured: Baseline, Week 4, Week 8
Dysfunctional Voiding Symptoms Score, DVSS
Subject will complete Dysfunctional Voiding Symptom Score (DVSS) at each visit to the clinic (baseline, week 4, week 8). The questionnaire consists of 10 voiding dysfunction parameters that are assigned scores of 0 to 3 according to prevalence. The subject can score minimum of 0 to maximum of 30 (severe dysfunctional voiding). The aim is to identify changes in total scoring throughout the trial period.
Measured: Baseline, Week 4, Week 8
Investigational Product (IP) Adherence and Accountability
Subject will return the used investigational product at each visit. A study coordinator or clinical researcher will manually count the left over pills. The IP adherence and accountability will be calculated as following equation: Number of tablet taken by the subject divided by number of tablets need to take, multipled by 100. The results of IP adherence and accountability will be expressed in percentage.
Measured: Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Il-Yang Pharm. Co., Ltd.
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
- Investigators
- Kwanjin Park, MD/PhD, Principal investigator, Seoul National University Hospital (Department of Urology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181591
- Sponsor's protocol ID
- H-2310-153-1481
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control 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)
- ClinicalTrials.gov ID
- NCT06181591
- Acronym / sponsor ID
- H-2310-153-1481
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Il-Yang Pharm. Co., Ltd.
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, parallel group, and active control comparator trial. The subject will be assigned either to Hibero (Mirabegron) 50 mg or Ditropan (Oxybutynin Chloride) 10 mg at baseline (randomization). The subject will be asked to take the IP or active comparator by mouth without crushing the pill for 8 weeks, and the frequency of oral administration depends on the prescribed method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hibero SR (Mirabegron) 50 mg | Experimental | Drug: Mirabegron 50 MGSubjects aged between 5 and 18 years will receive a daily dose of IP orally starting from baseline to week 8. |
| Ditropan (Oxybutynin Chloride) 10 mg | Active comparator | Drug: Oxybutynin Chloride 5 MGSubjects aged between 5 and 18 years will receive a daily dose of active comparator orally starting from baseline to week 8. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 50 MGAlso: Hibero, Myrbetriq, BetigmaMirabegron (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. | Drug | Hibero SR (Mirabegron) 50 mg |
| Oxybutynin Chloride 5 MGAlso: DitropanOxybutynin 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. | Drug | Ditropan (Oxybutynin Chloride) 10 mg |
Primary outcome
Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years
Time frame: Baseline, Week 4, Week 8
Subject will complete 2-days voiding diary (48 hours) before each visit. Maximum voided volume will be derived from the 2-day voiding diary.
4 secondary outcomes
Total frequency of urinary incontinence
Time frame: Baseline, Week 4, Week 8
Total frequency of urinary urgency
Time frame: Baseline, Week 4, Week 8
Dysfunctional Voiding Symptoms Score, DVSS
Time frame: Baseline, Week 4, Week 8
Investigational Product (IP) Adherence and Accountability
Time frame: Week 4, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwanjin Park, MD/PhD principal investigator
Seoul National University Hospital (Department of Urology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron 50 MG and Oxybutynin Chloride 5 MG in people with Overactive Bladder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwanjin Park, MD/PhD (+82-2072-0695, urodori9@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years (time frame: Baseline, Week 4, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.