E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The trial investigates the benefits of Kentera, a new transdermal preparation of oxybutynin for overactive bladder syndrome. The principal outcome measure is achievement of patient-selected goals, and compares this to more conventional quality of life and urinary frequency outcome measures. Patient-selected goals are an outcome measure designed to capture elements of the patient experience that would ordinarily be overlooked by clinicians. Allowing the patient to choose her own goals and then rate their achievement, reflects the improvements that actually matter to patients. |
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E.2.2 | Secondary objectives of the trial |
The main secondary outcome measure is "warning time". This is defined as the interval between first noticing strong desire to pass urine, and the moment when the patient does pass urine, or leak. This measure is important to patients because an increased warning time gives an increased time to find a toilet, reducing social inconvenience, and the possibility of leaking. Previous trials have shown that successful treatment with anticholnergic medicines can prolong warning time.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At study entry: 1. Female patient aged ©ø18 2. Written informed consent obtained 3. Patient is willing and able to complete the FVC and questionnaires correctly. 4. Symptoms of overactive bladder (frequency and/or urgency and/or urge incontinence) for at least 3 months and/or previously demonstrated DO at urodynamics.
At randomization: 1. At least three episodes of urgency or urge incontinence on FVC over 3 days. 2. Frequency greater than 8/day on FVC averaged over 3 days.
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E.4 | Principal exclusion criteria |
At study entry: 1. History of hypersensitivity to oxybutynin or any of the ingredients of Kentera 2. History of allergy from medical tape or transdermal skin patch. 3. Pregnancy, intention to become pregnant during study period, unreliable contraception despite being sexually active, breast feeding. 4. Urodynamic proven mixed incontinence. 5. Voiding difficulties (flow rate<15ml/s, or post void residual>50mls) 6. Patient with indwelling catheter or practicing CISC. 7. Evidence of current UTI or bladder stone or malignancy. 8. Uncontrolled narrow angle glaucoma, myasthenia gravis, gastric or urinary retention, moderate or severe renal impairment or dialysis, moderate or severe hepatic impairment, chronic intestinal disease (including ulcerative colitis and gastrointestinal obstruction), megacolon, diabetic neuropathy, oesophageal inflammation (hiatus hernia, gastrooesophageal reflux), Parkinson¡¯s disease, or other significant clinical condition (at the discretion of the investigator). 9. Other specific medications: anticholinergics, antispasmodics, anti-parkinsonian, tricyclics, tetracyclics, duloxetine, antihistamines, antiemetics, diuretics, neuroleptics, type I antiarrythmics, opioids, alpha-antagonists, CYP3A4 inhibitors or inducers, any other bladder medication.
At randomisation: 1. Failure to complete FVC according to instructions. . |
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E.5 End points |
E.5.1 | Primary end point(s) |
6 or 14 weeks, depending on patient choice. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
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
| 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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14 weeks. Completion of open phase of treatment. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |