A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB). Protocol for Phase I Study of solifenacin succinate suspension single ascending dose PK study.
Phase of Trial: Phase I
Latest Information Update: 26 Jul 2016
At a glance
- Drugs Solifenacin (Primary)
- Indications Overactive bladder
- Focus Pharmacokinetics
- Acronyms GIRAFFE
- Sponsors Astellas Pharma
- 28 Apr 2012 Additional locations added as reported by European Clinical Trials Database record.
- 28 Apr 2012 Status changed from active, no longer recruiting to completed as reported by United Kingdom Clinical Research Network.
- 16 Nov 2011 Actual initiation date (Sep 2010) added as reported by European Clinical Trials Database.