A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Patients 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurogenic Detrusor Overactivity
Intervention: Solifenacin succinate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Astellas Pharma Europe B.V. Official(s) and/or principal investigator(s): Clinical Study Manager, Study Chair, Affiliation: Astellas Pharma Europe B.V.
Summary
The purpose of this study is to investigate a medicine for the treatment of symptoms and
complications of neurogenic detrusor overactivity (NDO) in children and adolescents. 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 will be investigated. The take-up and
length of time that the solifenacin suspension stays in the body will also be investigated
during this study.
The study will last for approximately 12 months, where completing patients will receive 52
weeks of continuous treatment.
Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and
urine volumes measured during catheterization together with the diary responses relating to
the number of incontinence episodes or incontinence free days.
Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of
the kidney, simple memory and understanding tests (cognitive function) and the ability to
see near and far objects (visual accommodation).
Clinical Details
Official title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in maximum cystometric capacity (MCC)
Secondary outcome: Change in Maximum Cystometric Capacity (MCC)Change in Urodynamics Change in Diary Observations Change in Quality of Life
Eligibility
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Site: 3201, Gent 9000, Belgium
Site: 5504, Campinas 13083-887, Brazil
Site: 5506, Campinas, Brazil
Site: 5507, Curitiba, Brazil
Site: 5503, Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Site: 5505, São José do Rio Preto - SP 15090-000, Brazil
Site: 4501, Århus N DK-8200, Denmark
Site: 3602, Miskolc, Hungary
Site: 8201, Seoul 120752, Korea, Republic of
Site: 8207, Seoul 110744, Korea, Republic of
Site: 5203, Leon, GTO 37000, Mexico
Site: 5205, Mexico City, Mexico
Site: 6301, Manila 1015, Philippines
Site: 6302, Quezon City, Philippines
Site: 4803, Gdansk, Poland
Site: 4805, Gdansk, Poland
Site: 4801, Warszawa 04-730, Poland
Site: 9001, Ankara 6100, Turkey
Site: 9003, Ankara 6100, Turkey
Site: 9002, Izmir 35100, Turkey
Site: 1008, Tarrytown, New York 10591, United States
Site: 1010, Cincinnatti, Ohio 45229, United States
Additional Information
Starting date: September 2012
Last updated: July 27, 2015
|