A study to investigate how solifenacin fluid is taken up, how long it stays in the body and how effective and safe it is in treating children/adolescents aged 5 to less than 18 years with symptoms of overactive bladder (OAB) compared to a non-active drug.

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002066-20-GB

Enrollment

140

Registered

2012-01-04

Start date

2012-11-01

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857

Interventions

Product Name: Solifenacin Succinate Product Code: YM905 Pharmaceutical Form: Oral suspension INN or Proposed INN: SOLIFENACIN SUCCINATE CAS Number: 242478-38-2 Current Sponsor code: YM905 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? yes Number of subjects for this age range: 140 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of solifenacin succinate o.d. in children and adolescents with OAB ;Secondary Objective: To perform population pharmacokinetics after multiple-dose administration. ;Primary end point(s): Change from baseline in mean volume voided per micturition.;Timepoint(s) of evaluation of this end point: At each study visit	—

Secondary

Measure	Time frame
Secondary end point(s): Change from baseline in: •Maximum volume voided per micturition. •Mean number of daytime incontinence episodes/24 h. •Mean number of nighttime incontinence episodes/24 h. •Number of dry (incontinence-free) days/7 days •Mean number of daytime micturitions/24 h. •Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety variables: •AEs •Vital signs •Laboratory tests (including hematology and biochemistry) •Urinalysis •Post void residual volume(PVR) •12-lead ECG parameters. ;Timepoint(s) of evaluation of this end point: At each study visit	—

Measure

Time frame

Secondary end point(s): Change from baseline in: •Maximum volume voided per micturition. •Mean number of daytime incontinence episodes/24 h. •Mean number of nighttime incontinence episodes/24 h. •Number of dry (incontinence-free) days/7 days •Mean number of daytime micturitions/24 h. •Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety variables: •AEs •Vital signs •Laboratory tests (including hematology and biochemistry) •Urinalysis •Post void residual volume(PVR) •12-lead ECG parameters. ;Timepoint(s) of evaluation of this end point: At each study visit

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Countries

Belgium, Brazil, Canada, Denmark, France, Germany, India, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Serbia, South Africa, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactService Desk - Global Development O

Astellas Pharma Europe B.V.

contact@nl.astellas.com+31715455 878

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026