Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend).
A Study to Investigate How Effective and Safe Solifenacin Liquid 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 (LION)
PHRR121119-000017
2012-CT0019
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 will investigate the effect and safety of solifenacin suspension compared to a non-active drug (placebo) over a 14-week period of daily treatment. The study will also investigate how well solifenacin suspension is taken-up by the body and how long it stays in the body during this time.
| Regime | Classification | Priority |
|---|---|---|
| 2010 - 2016 | Health Technology Development | Drug Discovery and Development |
| Start Date | Duration in Months | Target Completion Date | Actual Completion Date |
|---|---|---|---|
| 2012-06-01 | 18 | 2013-12-01 | 0000-00-00 |
Ongoing
| Institution | Classification | Region | LTO # |
|---|---|---|---|
| PPD Development (S) PTE. LTD. | Private Business | NCR |
| Institution | Classification | Region | LTO # |
|---|---|---|---|
| Astellas Pharma Europe B.V. | Private Business | Netherlands |
| Institution | Region |
|---|---|
| Astellas Pharma Europe B.V. | Netherlands |
| Name | Institution and Institution Address | |
|---|---|---|
| Fridee-May Ortega | Fridee-May.Ortega@ppdi.com | 9/F Sun Life Centre 5th Avenue corner Rizal Drive Bonifacio Global City, Taguig |
| Name | Institution and Institution Address | |
|---|---|---|
| Dr. David Bolong | davebolong@gmail.com | Philippine Children's Medical Center, Quezon City |
| Name | Expertise | Affiliation |
|---|---|---|
| David Bolong, MD | Urologist | Philippine Children's Medical Center |
| Project Location | Institutional Ethics Review Board |
|---|---|
| Philippine Children's Medical Center | Philippine Children's Medical Center IRB - Ethics Committee |
Clinical Trial
Overactive Bladder
Change from baseline to EoT (final visit) in OAB symptoms [ Time Frame: Baseline and Week 12 ] o Maximum volume voided per micturition. o Mean number of daytime incontinence episodes/24 h. o Mean number of nighttime incontinence episodes/24 h. o Mean number of incontinence episodes/24 h. o Number of dry (incontinence-free) days/7 days. o Mean number of daytime micturitions/24 h. o Mean number of micturitions/24h. o Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Baseline and Week 12 ]
Recruiting
- Belgium
- Brazil
- Canada
- Denmark
- France
- Germany
- India
- Italy
- Mexico
- Netherlands
- Norway
- Philippines
- Poland
- Russia
- Serbia and Montenegro
- South Africa
- South Korea
- Sweden
- Turkey
- United Kingdom
Unspecified
Unspecified
0000-00-00
15
Unspecified
N/A
2012-10-22
Inclusion: • 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: • 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 • Post Void Residual (PVR) > 20 ml • Monosymptomatic enuresis • Congenital anomalies affecting lower urinary tract function • Current constipation • Current UTI
Interventional
Solifenacin Succinate Oral Suspension
Parallel assignment to solifenacin succinate oral suspension or placebo
None
| Method of Allocation |
Randomized |
|---|---|
| Masking or Blinding |
Double-blind |
| Masking Details |
Unspecified |
| Control |
Unspecified |
| Assignment |
Parallel |
| Phase |
Phase III |
| Purpose of the Study |
Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend). Change from baseline to EoT (final visit) in OAB symptoms [ Time Frame: Baseline and Week 12 ] o Maximum volume voided per micturition. o Mean number of daytime incontinence episodes/24 h. o Mean number of nighttime incontinence episodes/24 h. o Mean number of incontinence episodes/24 h. o Number of dry (incontinence-free) days/7 days. o Mean number of daytime micturitions/24 h. o Mean number of micturitions/24h. o Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Baseline and Week 12 ] |
| Detailed purpose of the study |
Unspecified |