Status:
COMPLETED
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with sy...
Detailed Description
This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent...
Eligibility Criteria
Inclusion
- Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
- Daytime urgency incontinence at least once/day
Exclusion
- Daytime voiding frequency less than 5
- Uroflow indicative of pathology other than OAB
- Maximum voided volume \> age expected capacity (\[age +1\] x 30) in ml
- Post voiding residual (PVR) \> 10% of the functional bladder capacity
- Monosymptomatic enuresis
- Congenital anomalies of the genito-urinary tract or nervous system
- Current constipation (when treated the patient can enter the study)
- Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
- Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN
Key Trial Info
Start Date :
October 20 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01262391
Start Date
October 20 2010
End Date
August 14 2011
Last Update
October 22 2024
Active Locations (8)
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1
Ghent, Belgium, 9000
2
Kortrijk, Belgium, 8500
3
Aarhus, Denmark, 8200
4
Gothenburg, Sweden, 41685