E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Overactive bladder syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029279 |
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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 change in the quality of life and symptomatology score (as assessed using the scoring in the King’s Health Questionnaire (KHQ)) 6 Weeks after treatment with Botulin Toxin type A in comparison with the baseline score. |
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E.2.2 | Secondary objectives of the trial |
To assess the change in the quality of life and symptomatology score (as assessed using the scoring in the KHQ) following treatment with Botulinum toxin Type A at all other time points in comparison with the baseline score. To assess the change in urodynamic parameters (volume at first detrusor contraction, detrusor compliance, maximum cystometric bladder capacity and post-void residual volume (as measured by ultrasound of the bladder). To assess the change in patient satisfaction with treatment (as assessed using the numerical rating scale). To assess the change in past-24 hour continence check findings. To assess the changes in bladder diary parameters. To compare the anticholinergic medication requirement at each assessment time point in comparison to the baseline visit. To assess the safety of treatment with Botulinum toxin Type A . |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. The patient must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care. 2. The patient must be between 18 and 75 years of age inclusive. 3. The patient must have a clinical diagnosis of Overactive Bladder Syndrome without any neurogenic cause, with or without evidence of detrusor overactivity on conventional urodynamic assessment. 4. The patient must have Overactive Bladder Syndrome resistant to anticholinergic medication, or suffer unacceptable side effects from anticholinergic therapy. 5. The patient must be fit for flexible cystoscopy under local anaesthetic. 6. The patient must be willing and able to use clean intermittent self-catheterisation (CISC) if this becomes necessary. 7. The patient must be competent to give informed consent. 8. The patient must be able and willing to comply with the requirements of the protocol.
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E.4 | Principal exclusion criteria |
1. The patient has significant coexisting genuine stress incontinence. 2. The patient is suffering from any severe concomitant medical illness, or has significantly reduced renal or hepatic function. 3. The patient has concurrent other bladder pathology. 4. The patient has an indwelling catheter. 5. The patient has coexisting myaesthenia gravis. 6. The patient has a persistent urinary infection or un-investigated haematuria (if patients are diagnosed with a urinary tract infection at screening, part 2 of the screening assessments will be postponed until the infection had resolved). 7. The patient has a history of blood clotting disorders, or is on warfarin. 8. The patient has any other serious illness or medical condition that in the opinion of the investigator would jeopardise the efficacy or safety of this treatment or of the study assessments. 9. The patient has any contraindication to the use of Botulinum toxin (any serotype). 10. The patient has a known allergy or hypersensitivity to clostridium botulinum neurotoxin complex or to any of the excipients. 11. The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile or < 1 year post-last menstrual period) must have a negative pregnancy test on the day of injection. 12. The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy. 13. The patient is receiving anticholinergic medication for which the dose has not been stable for at least 12 weeks prior to the baseline visit. 14. The patient is currently treated with, or has been treated during the week prior to the study with medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics. 15. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period. 16. The patient has previously entered this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in quality of life and symptomatology score (as assessed using the scoring in the ten domains of the King’s health questionnaire (KHQ)) at Week 6 in comparison with the baseline score. |
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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 | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
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The end of the trial is the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |