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 |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 11/1/2018 |
| Start Date: | June 7, 2012 |
| End Date: | January 2, 2014 |
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
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.
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.
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
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