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: 16.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2011-002047-10-SE
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
-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
- Secondary Outcome Measures
Name Time Method