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

Astellas

Status and phase: Completed; Phase 3

Conditions: Neurogenic Detrusor Overactivity

Treatments: Drug: Solifenacin succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565694

2011-000330-11 (EudraCT Number)

905-CL-047

Details and patient eligibility

About

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.

Full description

The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.

The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.

The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.

Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).

Enrollment: 76 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Solifenacin succinate

Experimental group

Description:

Participants aged 5 years to \< 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg. After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52).

Treatment:

Drug: Solifenacin succinate