E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neurogenic detrusor overactivity |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029279 |
E.1.2 | Term | Neurogenic bladder |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of solifenacin 10mg compared to placebo in patients with neurogenic detrusor overactivity |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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. |
|
E.4 | Principal exclusion criteria |
1. Subjects with neurogenic detrusor overactivity due to Parkinsons or cerebrovascular disease. 2. Subjects with Sjögrens 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Maximum cystometric capacity at end point visit |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |