076: Phase 3 Study of Solifenacin vs Placebo in Children with OAB

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of Age with Overactive Bladder (OAB).

• IRAS ID

  98565

• Contact name

  Prasad Godbole

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-002066-20

• Research summary

  The purpose of this study, sponsored by Astellas, is to investigate a medicine for the treatment of symptoms of overactive bladder (OAB) and wetting in children and adolescents. OAB is a condition affecting the bladder, where patients experience urgency symptoms. Urgency is the sudden and unexpected need to empty the bladder, and is only described in patients older than 5 years or after bladder control has developed. The medicine tested in this study is called solifenacin. Solifenacin tablets are given to adults for the treatment for OAB. A new liquid suspension has been developed to treat children and adolescents in this study. The effect and safety of the solifenacin suspension compared to non-active drug (placebo) will be investigated over a 14-week period of daily treatment. The study will also investigate how well solifenacin suspension is taken-up by the body and how long it stays in the body during this time. The starting dose is equivalent to the 5 mg dose used in adults and may be adjusted up to 3 times to establish the most suitable dose for each patient. The study is double-blind meaning that all the treatments look the same. Neither the patient nor the doctor will know which treatment is being received unless there is a medical emergency. The study duration is approximately 4 months, including 14 weeks of continuous study medication (solifenacin or matching placebo). During the entire study all patients will receive bladder training, which is the first-line treatment for OAB. The study involves 8 visits to the study site. Patients will need to complete a toilet diary before visit 2 and for every visit up to visit 7. Further assessments include the measurement of residual urine, ECG, blood and urine testing. In total about 400 children or adolescents aged 5-17 will take part worldwide.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  12/YH/0089

• Date of REC Opinion

  1 Nov 2012

• REC opinion

  Further Information Favourable Opinion