Study of Solifenacin Suspension in children with Overactive Bladder

• Research type

  Research Study

• Full title

  A Multicentre, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Paediatric Subjects from 5 to less than 18 years of age with Neurogenic Detrusor Overactivity (NDO).

• IRAS ID

  92093

• Contact name

  Prasad Godbole

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-000250-28

• ISRCTN Number

  n/a

• Research summary

  Neurogenic Detrusor Overactivity (NDO) is Detrusor Overactivity associated with a neurological condition. There is an incidence of 1.8 per 10, 000 births in the EU. Overactive Detrusor function is involuntary detrusor contractions that lead to uninhibited bladder contractions, low bladder capacity and compliance or lack of effective contractions. Incontinence is a common symptom. NDO can develop due to a lesion in the nervous system. The most common cause in children is myelodysplasia (developmental abnormalities). Congenital and acquired conditions can also lead to NDO. Standard treatments include clean intermittent catheterization (CIC) and use of antimuscarinics to suppress detrusor Overactivity. 90% of patients are treated successfully with the Oxybutanin and CIC. However the use of other drugs is limited in children with NDO. Botulism A toxin injections have been used in children not responding to standard therapy with CIC and antimuscarinics. Solifenacin Succinate is used to relieve symptoms of urinary frequency, incontinence and urgency in adults with an overactive bladder (OAB) and is known to be effective and safe. There have been no studies of Solifenacin Succinate in paediatric NDO patients however there have been investigator studies which indicate that Solifenacin Succinate is efficacious and generally well tolerated. The purpose of this study is to evaluate blood levels of solifenacin succinate in children after taking a single oral dose. The safety profile of will also be evaluated. 12 patients will be enrolled into the study with 1 site in UK. The duration of participation will be 1 week with 1 single-dose of treatment. There is up to 4 weeks allowed for screening. Participants will have 5 visits to the study site and have procedures including weight, physical examination, vital signs, ECG, blood and urine testing and drug and alcohol screening. The study is sponsored by Astellas Pharma Europe B.V.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0440

• Date of REC Opinion

  10 Feb 2012

• REC opinion

  Further Information Favourable Opinion