A study to investigate how safe and effective solifenacin fluid is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076.
- Conditions
- Overactive Bladder (OAB)MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2011-002047-10-GB
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 148
-OAB (symptoms of urgency) according to International Children’s Continence Society (ICCS) criteria
-Daytime incontinence with at least 4 or more episodes of incontinence
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of solifenacin succinate suspension once daily in children and adolescents with OAB.;Secondary Objective: ;Primary end point(s): Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Efficacy:<br> Change from baseline in:<br> •mean number of daytime incontinence episodes/24 h.<br> •mean number of nighttime incontinence episodes/24 h.<br> •number of dry (incontinence-free) days/7 days.<br> •mean number of daytime micturitions/24 h.<br> •mean number of grade 3 or 4 urgency episodes per 24 hr in adolescents.<br> Safety:<br> •Vital signs<br> •Laboratory tests (including hematology and biochemistry)<br> •Urinalysis<br> •PVR (post void residual) volume<br> •ECG parameters<br> ;Timepoint(s) of evaluation of this end point: At each study visit