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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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