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Be Part of Research - Trial Details - Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Completed

Open to: ALL

Age: 5.0 - 17.0

Medical Conditions

Urinary Bladder, Overactive


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2012 Aug 2012

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

Intervention Arm Group : AD-PED 5 mg;CH-PED 5 mg;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Site: 44
    Sheffield
    S10 2TH


The study is sponsored by Astellas Pharma Inc




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Read full details for Trial ID: NCT01539707
Last updated 20 October 2024

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