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)

Astellas

Status and phase: Completed; Phase 3

Conditions: Pediatric; Neurogenic Detrusor Overactivity

Treatments: Drug: Solifenacin succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981954

905-CL-074

2012-003178-22 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

In some children with a severe form of spina bifida (which is the consequence of a spinal cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also known as neurogenic detrusor overactivity) and the urethra (the passage connecting the bladder with outside) does not relax. Though these children cannot void, urine leakage can happen when the overactive contractions are strong, and/or the pressure in the bladder is so high that it overcomes the closed urethra (overflow at high filling bladder pressure). This high bladder pressure puts these children at risk for kidney damage and can decrease the quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and the overactive detrusor contractions.

Enrollment: 23 patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Solifenacin succinate

Experimental group

Description:

Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.

Treatment:

Drug: Solifenacin succinate