E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of overactive bladder with symptoms of frequency, urgency, and urgency incontinence (Some patients will also have urgency urinary incontinence (UUI)). |
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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 | 10059617 |
E.1.2 | Term | Overactive bladder |
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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 long-term efficacy, in terms of maintenance of Fesoterodine effect on urgency episode frequency in elderly subjects with OAB. |
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E.2.2 | Secondary objectives of the trial |
• To assess the long-term safety and tolerability of Fesoterodine in elderly subjects with OAB. • To assess the long-term efficacy, in terms of maintenance of Fesoterodine effect on other OAB symptoms, and on patient reported outcomes, in elderly subjects with OAB.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Completed the A0221045 trial and has been recommended by the investigator for extended use of Fesoterodine
2. Able and willing to complete all the trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures.
3. Capable of understanding and has signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits.
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E.4 | Principal exclusion criteria |
1. Any condition that would contraindicate their usage of Fesoterodine including: hypersensitivity to the active substance (Fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
2. Predominant Stress Incontinence. Stress urinary incontinence as determined/estimated by the investigator.
3. Participated in any clinical trial other than A0221045 or received any other investigational drug within 4 weeks prior to enrollment Visit.
4. Other severe or acute medical condition (including newly diagnosed diabetes mellitus or newly diagnosed hypertension requiring treatment, or major hematological or cardiovascular conditions) or psychological condition or social circumstances that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of the study results or may impair ability to participate reliably in the trial, or may increase the risk to themselves or others as judged by the investigator.
5. Abuse of alcohol and/or any other drug in the opinion of the investigator.
6. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Mean number of micturition-related urgency episodes per 24h at end of treatment. Micturition-related urgency episodes are defined as those with Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the diary. |
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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 | 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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
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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This study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine until it is commercially available in Portugal or until 31st Dec 2011 (whichever is sooner). |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |