CompletedPhase 3

A Clinical 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 Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

United States, Belgium, Philippines23 participantsStarted 2013-09-25

Plain-language summary

The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

Who can participate

Age range6 Months – 4 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Myelomeningocoele * Documented diagnosis of NDO, confirmed by urodynamics * DSD (detrusor sphincter dyssynergia) * Practicing clean intermittent catheterization (CIC) Exclusion Criteria: * Know genitourinary condition (other than NDO) that may cause incontinence * Bladder augmentation surgery * Current faecal impaction * Electro-stimulation therapy within 2 weeks prior to visit * Subjects with the following gastro-intestinal problems: partial or complete obstructions, decreased motility like paralytic ileus, subjects at risk of gastric retention * Reflux grade 3 to 5 * Current urinary tract infection

What they're measuring

Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT01981954

SponsorAstellas Pharma Europe B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-18

Results submitted2018-05-23

View on ClinicalTrials.gov More Neurogenic Detrusor Overactivity trials