077: Phase 3 Extension Study of Solifenacin in Children with OAB

• Research type

  Research Study

• Full title

  An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB).

• IRAS ID

  98710

• Contact name

  Prasad Godbole

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-002047-10

• 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. 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. This is an open-label study to investigate the effect and safety of long??term, once-daily treatment with solifenacin suspension when given to children and adolescents with OAB. Patients who have completed study 905-CL-076 can be included into this study (905-CL-077). Each patient will be treated with the solifenacin succinate suspension for up to 40 weeks. For most patients, the starting dose will be equivalent to the 5 mg dose used in adults, but some patients may start on the 2.5 mg dose, if this was considered their optimum dose for 905-CL-076. The dose may be adjusted up to 3 times (during the first 12 weeks) to establish the most suitable dose for each patient. Participants will continue on their optimum dose until the end of the study. The study involves 7 visits to the study site. The first study visit of 905-CL-077 will also be the last study visit for 905-CL-076. Patients will need to complete a toilet diary for 7 days prior to each visit. Further assessments include the measurement of residual urine, ECG, blood and urine testing. In total about 120 children or adolescents, who were aged 5 to 17 years at the beginning of their participation in study 905-CL-076, will take part.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  12/YH/0087

• Date of REC Opinion

  1 Nov 2012

• REC opinion

  Further Information Favourable Opinion