A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension … (NCT01565694) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
United States, Belgium, Brazil76 participantsStarted 2012-08-14
Plain-language summary
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Who can participate
Age range5 Years – 17 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:
* Documented diagnosis of NDO, confirmed by urodynamics
* Practicing clean intermittent catheterization (CIC)
* Currently on treatment with an antimuscarinic drug
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 or 4
* Current urinary tract infection (UTI)
* Subject has severe renal impairment (glomerular filtration rate \< 30 ml/min)
* Subject has severe hepatic impairment (Child-Pugh score \> 9).
* Subject has received intra-vesical botulinum toxin within 9 months prior to screening
What they're measuring
1
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)