Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 13, 2012

Primary Completion Date

August 13, 2012

Study Completion Date

August 13, 2012

Conditions
Overactive BladderNeurogenic Detrusor Overactivity
Interventions
DRUG

Solifenacin succinate suspension 5 mg

Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

Trial Locations (7)

6100

Site: 90, Ankara

9000

Site: 3201, Ghent

G1V 4G2

Québec

DK-8200

Site: 4501, Århus N

3584 EA

Site: 3102, Utrecht

04-730

Site: 4801, Warsaw

S10 2TH

Site: 44, Sheffield

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY

NCT01539707 - Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder | Biotech Hunter | Biotech Hunter