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
- Conditions
- Neurogenic Detrusor Overactivity
- Registration Number
- CTRI/2012/12/003252
- Lead Sponsor
- Astellas Pharma Europe BV
- Brief 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).
Study has been discontinued in India.
No Subjects were screened or enrolled for the study in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 74
- Documented diagnosis of NDO, confirmed by urodynamics.
- Practicing clean intermittent catheterization (CIC).
- Currently on treatment with an antimuscarinic drug.
- 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 less than 30 ml/min).
- Subject has severe hepatic impairment (Child-Pugh score greater than 9).
- Subject has received intra-vesical botulinum toxin within 9 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in maximum cystometric capacity (MCC) Baseline and Week 24
- Secondary Outcome Measures
Name Time Method Change in Maximum Cystometric Capacity (MCC) Baseline, Week 9, Week 24 and Week 52 Change in Urodynamics Measured by: Change in Diary Observations Measured by: Change in Quality of Life Baseline, Week 24 and Week 52
Trial Locations
- Locations (4)
Bodyline Hospitals
🇮🇳Ahmadabad, GUJARAT, India
Dr. Ram Manohar Lohia Hospital & PGIMER
🇮🇳Delhi, DELHI, India
Himalayan Institute of Medical Sciences
🇮🇳Dehradun, UTTARANCHAL, India
Inamdar Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Bodyline Hospitals🇮🇳Ahmadabad, GUJARAT, IndiaDr Shailesh Anantray ShahPrincipal investigator919824035673shaileshshahuro@yahoo.com