A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg once daily) against Placebo and Oxybutynin Hydrochloride (5 mg three times daily) in the Treatment of Subjects with Neurogenic Detrusor Overactivity - SONIC
- Conditions
- eurogenic detrusor overactivityMedDRA version: 9.1Level: LLTClassification code 10029279Term: Neurogenic bladder
- Registration Number
- EUCTR2006-005523-42-IT
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
1. Male or female subjects aged 18 years or over. 2. Written informed consent has been obtained. 3. Subjects with neurogenic detrusor overactivity due to: Multiple sclerosis (MS) (EDSS equal or minor to 8) Or Spinal cord injury (SCI) (partial and complete lesions). 4. MS or SCI symptoms should be stable for 6 months or more. 5. Neurogenic detrusor overactivity symptoms should be stable for 6 months or more. 6. Subject is willing and able to perform clean, intermittent, catheterization, if required. 7. Subject is willing and able to take study medication in compliance with the protocol.
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
1. Subjects with neurogenic detrusor overactivity due to Parkinson?s or cerebrovascular disease. 2. Subjects with Sjögren?s Syndrome or any similar symptoms. 3. Subjects with 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. Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator. 5. Subjects with evidence of pressure sores grade 2 or more. 6. Subjects with a history of bladder sphincterotomy. 7. Subjects with 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. Subjects undergoing hemodialysis. 10. Subjects with severe hepatic impairment. 11. Concurrent use of drugs intended to treat symptoms of overactive bladder. 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. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives. 18. Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer. 19. Employees of the Astellas Group, third parties associated with the study, or the study site. Visit 2: 20. Subject with maximum bladder capacity 400ml or more.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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): Maximum cystometric capacity at end point visit
- Secondary Outcome Measures
Name Time Method