A0221047 Paediatric NDO study
Research type
Research Study
Full title
A 12-week randomized, open-label, active comparator period followed by a 12-week safety extension period to evaluate the safety and efficacy of Fesoterodine in subjects aged 6 to 16 years and >25 kg with symptoms of detrusor overactivity associated with a neurological condition (Neurogenic Detrusor Overactivity).
IRAS ID
109044
Contact name
Malcolm Lewis
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2010-022475-55
Duration of Study in the UK
2 years, 3 months, 4 days
Research summary
Few medicines are approved for the treatment of Neurogenic Detrusor Overactivity (NDO) in children. This is because there is not enough research information about their safety or efficacy in children.
NDO frequently makes it difficult for patients to control their urine, leading to episodes of incontinence. Many also need to pass a tube into the bladder to empty it properly (also known as catheterization). The purpose of this research study is to learn about the effects of the study drug, Fesoterodine in patients with NDO. The study will be looking at the number of wetting events, catheterizations or how often urine (pee) is passed, bladder function and side effects. In addition, we will be able to compare its effects to Oxybutynin, a widely approved medicine commonly used to treat NDO in children.
Although Fesoterodine is approved in Europe and the USA for the treatment of overactive bladder and NDO in adults, it is not currently approved to treat NDO in children so the use of Fesoterodine in this study is investigational. Oxybutynin will be provided during the study as a comparison.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0694
Date of REC Opinion
18 Dec 2012
REC opinion
Further Information Favourable Opinion