Neurogenic detrusor overactivity. MedDRA version: 9.1 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia
Conditions
Interventions
Trade Name: Vesicare, tablets 5 mg
Product Name: solifenacin 5 mg tablet
Product Code: YM905 5 mg tablet
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years or over. 2. Written informed consent. 3. Subjects with neurogenic detrusor overactivity due to multiple sclerosis (MS) (EDSS=8) or spinal cord injury (SCI) (partial and complete lesions) 4. MS or SCI symptoms stable for 6 months or more. 5. Neurogenic detrusor overactivity symptoms stable for 6 months or more. 6. Subject is willing and able to perform clean, intermittent, catheterization, if required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Neurogenic detrusor overactivity due to Parkinson’s or cerebrovascular disease. 2. Sjögren’s Syndrome or any similar symptoms. 3. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs. 4. Stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator. 5. Evidence of pressure sores grade 2 or more. 6. History of bladder sphincterotomy. 7. Known history of vesico-ureteral reflux without upper urinary tract infection. 8. Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber. 9. Undergoing haemodialysis. 10. Severe hepatic impairment. 11. Concurrent use of drugs intended to treat overactive bladder symptoms. 12. Use of antidepressants or muscle relaxants which have not been administered at a constant dose for 3 months or more. 13. Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilliods therapy in the six months prior to the commencement of the study. 14. Use of permanent, indwelling catheters. 15. Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose. 16. Concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole. 17. Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. 18. Maximum bladder capacity 400 ml or more.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of solifenacin 10mg compared to placebo in patients with neurogenic detrusor overactivity;Secondary Objective: To assess the efficacy of solifenacin 5mg compared to placebo in patients with neurogenic detrusor overactivity To assess the efficacy of solifenacin compared to oxybutynin in patients with neurogenic detrusor overactivity To assess the safety and tolerability of solifenacin compared to placebo in patients with neurogenic detrusor overactivity To assess the safety and tolerability of solifenacin compared to oxybutynin in patients with neurogenic detrusor overactivity ;Primary end point(s): Change from baseline to end point in maximum cystometric capacity. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed