Trial · NCT06181591
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, Phase 2, Unknown, Seoul National University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT06181591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06181591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT06181591
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Overactive Bladder
- Interventions
- Mirabegron 50 MG, Oxybutynin Chloride 5 MG
- First posted
- 2023-12-26
- Last updated
- 2024-03-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to weeke 8 in maximum volume voided (MVV) per 48 hours for age group 5 to 18 years | 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. |
| Secondary | Total frequency of urinary incontinence | Baseline, Week 4, Week 8 | 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. |
| Secondary | Total frequency of urinary urgency | Baseline, Week 4, Week 8 | 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. |
| Secondary | Dysfunctional Voiding Symptoms Score, DVSS | Baseline, Week 4, Week 8 | 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. |
| Secondary | Investigational Product (IP) Adherence and Accountability | Week 4, Week 8 | 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. |
| Other | Patient Reported Treatment Emergent Adverse Events | Week 4, Week 8, Week 10 (Safety Monitoring TC) | Either the subject or guardian will report patient reported treatment emergent adverse events either at each visit or safety monitoring TC. |
| Other | Adverse Events of Special Interests (AESI) | Week 4, Week 8, Week 10 (Safety Monitoring TC) | Either the subject or guardian will report adverse events of special interests (AESI) either at each visit and safety monitoring TC. A list of AESI is varied depending on the type of IP (Hibero or Ditropan). |
| Other | Cardiovascular safety profile: ECG QT Interval | Screening, Baseline, Week 4, Week 8 | Subject will be monitored of cardiovascular safety profile (ECG QT Interval) throughout the trial. |
| Other | Cardiovascular safety profile: Pulse rate | Screening, Baseline, Week 4, Week 8 | Subject will be monitored of cardiovascular safety profile (pulse rate) using a standard blood pressure machine. The unit for pulse rate is bpm (beats per minute). |
| Other | Cardiovascular safety profile: Blood Pressure | Screening, Baseline, Week 4, Week 8 | Subject will be monitored of cardiovascular safety profile (blood pressure) using a standard blood pressure machine. The unit for both systolic and diastolic blood pressure are mmHg. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06181591
GET https://conductscience.org/api/trials/v1/NCT06181591/registered