An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)
Phase 3
Completed
- Conditions
- Overactive Bladder/Urine incontinence10004994
- Registration Number
- NL-OMON37713
- Lead Sponsor
- Astellas Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
-OAB (symptoms of urgency) according to International Children*s Continence Society (ICCS) criteria ;-Daytime incontinence with at least 4 or more episodes of incontinence
Exclusion Criteria
-Daily voiding frequency less than 5.;-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.;-PVR > 20 ml ;-Monosymptomatic enuresis;-Congenital anomalies affecting lower urinary tract function ;-Current constipation ;-Current UTI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary variable:<br /><br>Incidence and severity of adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary variables:<br /><br><br /><br>Efficacy:<br /><br>Change from baseline of study 905-CL-076 to end of this study in:<br /><br>· mean number of daytime incontinence episodes/24 h.<br /><br>· mean number of nighttime incontinence episodes/24 h.<br /><br>· mean number of incontinence episodes/24 h<br /><br>· number of dry (incontinence-free) days/7 days.<br /><br>· mean number of daytime micturitions/24 h.<br /><br>· mean number of micturitions/24 h.<br /><br>· mean number of grade 3 or 4 urgency episodes per 24 hr in adolescents.<br /><br><br /><br>Safety:<br /><br>· Vital signs<br /><br>· Laboratory tests (including hematology and biochemistry)<br /><br>· Urinalysis<br /><br>· PVR (post void residual) volume<br /><br>· ECG parameters</p><br>