A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension i… (NCT02526979) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
Denmark, Poland9 participantsStarted 2015-12-17
Plain-language summary
The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB).
This study will also evaluate the safety and tolerability as well as the acceptability and palatability of mirabegron oral suspension after single dose administration in children with NDO or OAB.
Who can participate
Age range
3 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is male or female from 3 to less than 12 years of age.
* Subject has a documented diagnosis according to the International Children's Continence Society (ICCS) criteria of:
* NDO, or
* Idiopathic OAB
* Subject's weight/height:
* Subject must have a body weight of ≥ 15.0 kg
* For NDO: subject is not suffering from malnutrition or is not grossly overweight, in the opinion of the Investigator
* For OAB: subject's weight and height are within the normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts.
* Subject is able to swallow the study medication in accordance with the protocol.
* Subject and subject's parent(s)/legal guardian agree that the subject will not participate in another interventional study while on treatment.
* Subject and subject's parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.
* Female subject must:
* Be of non-childbearing potential: Clearly pre-menarchal or in the judgment of the Investigator is pre-menarchal.
* Or the following inclusion criteria are to be followed, if applicable (rare cases): Female subject that reached puberty must: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration, And have a negative urine pregnancy test predose Day 1, And, if heterosexually active agree to consistently use 2 forms …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.