047: Phase 3 Study of Solifenacin in children with NDO

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO).

• IRAS ID

  96046

• Contact name

  Prasad Godbole

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-000330-11

• Research summary

  This study involves the treatment of children with neurogenic detrusor overactivity (NDO); a neurological condition that causes contractions of the bladder whilst it fills with urine. Most children with NDO suffer from a severe abnormality of the spine. The muscles that close the bladder are affected, so that these children need to empty their bladder with a catheter. Even though the child cannot urinate, they do sometimes leak. Treatment consists of inserting a germ-free catheter at fixed times during the day to empty the bladder (CIC) and drugs to relax the bladder (antimuscarinics). This means that the bladder pressure is kept low and that the number of contractions during filling is reduced. The bladder wall keeps its elasticity and more urine can be stored. This therapy protects the bladder and prevents kidney damage. The most commonly used antimuscarinic is oxybutynin. However, oxybutynin can enter the brain and side effects like learning difficulties are known. Less side effects are expected with solifenacin. Solifenacin has been given to some children and in 4 publications was shown to be safe and effective. The purpose of this study is to measure long-term effectiveness and safety, and the blood levels of solifenacin succinate in children with NDO after continuous daily dosing. The starting dose equals 5 mg in adults. The dose may be adjusted up to 3 times depending on the effectiveness and safety of the 5mg dose. In total 74 children aged 5-17 will take part worldwide. The duration of the study is one year with 10 visits to the study site. The pressures in the bladder and the bladder volume will be assessed with urodynamic investigations. Other procedures to assess safety are an eye test (because antimuscarinics, like solifenacin, may flunce eye accommodation), a cognition (memory and understanding) test, ECG, blood and urine testing.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  12/YH/0088

• Date of REC Opinion

  16 Jul 2012

• REC opinion

  Further Information Favourable Opinion