Overview

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

Status:
Completed
Trial end date:
2016-04-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Europe B.V.
Treatments:
Solifenacin Succinate
Criteria
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