798-110 GIRAFFE Paediatric patients with overactive bladder
Research type
Research Study
Full title
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)
IRAS ID
55033
Contact name
Daniel Carroll
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2009-017197-21
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
The aim of this study is to look at what happens to the study drug, solifenacin succinate suspension, in the body after a single-dose has been given at different dose levels to children and adolescents with Overactive Bladder (OAB). OAB is a syndrome affecting the filling of the bladder leading to a sudden, unexpected and immediate need to urinate. Symptoms can also include urge incontinence which is the uncontrollable leakage of urine when they feeling the urge to urinate. Patients may also urinate more frequently than normal. Some current standard treatments can result in significant side effects and are used off-label for paediatric use, although there are some drugs available that have been approved for paediatric use. Existing therapies show there is a need for new, different and innovative treatments and the treatment in this study has the advantage of a single daily dose. The study drug, solifenacin (trade name Vesicare©), is currently marketed as a tablet for adult use for the treatment of urge incontinence and/or increased frequency and urgency to urinate as may occur in OAB. Tablets are not suitable for treating children/adolescents, therefore the sponsor (Astellas) has developed an oral liquid, which will be used for clinical trials in all age groups, and finally for commercial use.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/38
Date of REC Opinion
24 Aug 2010
REC opinion
Further Information Favourable Opinion