A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

• Status: Completed
• Trial end date: 2014-01-02
• Target enrollment: 0
• Participant gender: All

Summary

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Solifenacin Succinate

Criteria

Main Inclusion Criteria:

• Written Informed Consent has been obtained

• OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria

• Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary

Main Exclusion Criteria:

• Daily voiding frequency less than 5

• Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition

• Uroflow indicative of pathology other than OAB

• Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml

• Post Void Residual (PVR) > 20 ml

• Monosymptomatic enuresis

• Polyuria defined as > 75 ml/kg/b.w./24 hours

• Dysfunctional voiding

• Congenital anomalies affecting lower urinary tract function

• Current constipation

• Current Urinary Tract Infection (UTI)

• Catheterization within 2 weeks prior to screening