A study to investigate how a drug is taken up, how long it stays in the body and how effective and safe it is in treating children with symptoms of neurogenic detrusor overactivity (NDO).

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000330-11-GB

Enrollment

Registered

2012-01-04

Start date

2012-07-16

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Neurogenic Detrusor Overactivity (NDO) MedDRA version: 17.1 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia System Organ Class: 100000004857

Interventions

Product Name: Solifenacin Succinate Product Code: YM905 Pharmaceutical Form: Oral suspension INN or Proposed INN: Solifenacin succinate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Documented diagnosis of NDO, confirmed by urodynamics -Practicing clean intermittent catheterization (CIC). -Currently on treatment with an antimuscarinic drug Are the trial subjects under 18? yes Number of subjects for this age range: 50 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: -Known genitourinary condition (other than NDO) that may cause incontinence -Bladder augmentation surgery. -Current Faecal impaction. -Electro - stimulation therapy within 2 weeks prior to screening and at any time during the study. -Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention. -Reflux grade 3 to 5. -Current UTI

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy, safety and PK of solifenacin succinate suspension after multiple dose administration.;Secondary Objective: ;Primary end point(s): Change in maximum cystometric capacity (MCC);Timepoint(s) of evaluation of this end point: Visit 3, 9, 24, 52.	—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At each study visit; Secondary end point(s): Urodynamic variables Change from baseline in: ? Bladder compliance ? Bladder volume until first detrusor contraction (> 15 cmH2O); ? Number of overactive detrusor contractions (> 15 cmH2O) until leakage or maximum 135% of age-related bladder capacity; ? Detrusor pressure at leakage or 135% of age-related cystometric capacity. o Mean number of incontinence episodes o Number of dry (incontinence-free) days/7 days. o Quality of life. Safety: AEs, clinical laboratory evaluations, vital organs, ECG and physical examination. PK variables	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At each study visit; Secondary end point(s): Urodynamic variables Change from baseline in: ? Bladder compliance ? Bladder volume until first detrusor contraction (> 15 cmH2O); ? Number of overactive detrusor contractions (> 15 cmH2O) until leakage or maximum 135% of age-related bladder capacity; ? Detrusor pressure at leakage or 135% of age-related cystometric capacity. o Mean number of incontinence episodes o Number of dry (incontinence-free) days/7 days. o Quality of life. Safety: AEs, clinical laboratory evaluations, vital organs, ECG and physical examination. PK variables

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Countries

Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, India, Italy, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Russian Federation, Turkey, United Kingdom, United States

Contacts

Public ContactService Desk - Global Development O

Astellas Pharma Europe B.V.

contact@nl.astellas.com+31715455878

Outcome results

None listed

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