The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
Who can participate
Age range3 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has a body weight of greater than or equal to 11 kg.
* Subject suffers from NDO confirmed by urodynamic investigation at baseline. The diagnosis of NDO must be confirmed by the presence of at least 1 involuntary detrusor contraction \> 15 cm H2O from baseline detrusor pressure, and/or a decrease in compliance leading to an increase in baseline detrusor pressure of \> 20 cm H2O.
* Subject has been using CIC for at least 4 weeks prior to visit 1/screening.
* Subject has a current indication for drug therapy to manage NDO.
* Subject is able to take the study drug in accordance with the protocol
Exclusion Criteria:
* Subject has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence or kidney/bladder stones or another persistent urinary tract pathology that may cause symptoms.
* Subject has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, subjects at risk of gastric retention.
* Subject has a urinary indwelling catheter within 4 weeks prior to visit 1/screening.
* Subject has a surgically treated underactive urethral sphincter
* Subject has vesico-ureteral reflux grade 3 to 5.
* Subject has undergone bladder augmentation surgery.
* Subject receives electrostimulation therapy, if started within 30 days before visit 1/screening or is expected to start during the study period. Subjects who are on an established regimen may rema…
What they're measuring
1
Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24