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