Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-12-03
Brief 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
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None