Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

• Status: Completed
• Trial end date: 2011-08-14
• Target enrollment: 0
• Participant gender: All

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 symptoms of overactive bladder.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria

• Daytime urgency incontinence at least once/day

Exclusion Criteria:

• 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