E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overactive bladder (OAB) with symptoms of urgency urinary incontinence, urgency and urinary frequency. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effects of fesoterodine on quality of life (QoL) and secondary micturition diary endpoints in OAB patients who were dissatisfied with their prior therapy with tolterodine. 2. To evaluate tolerability and safety of fesoterodine in OAB patients who were dissatisfied with their prior therapy with tolterodine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Male or female outpatients ≥ 18 years old. 2. Overactive bladder symptoms (subject-reported) for ≥ 3 months prior to Screening/Visit 1. 3. Previously treated (within 2 years prior to Screening) or being treated with tolterodine or tolterodine ER for OAB. 4. Reported being “somewhat dissatisfied” or “very dissatisfied” with their prior treatment with tolterodine or tolterodine ER on the prior Treatment Satisfaction Question (pTSQ) at Screening/ Visit 1. 5. Mean urinary frequency of ≥ 8 micturitions per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2. 6. Mean number of Urgency episodes ≥ 3 per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Bladder Sensation Scale rating ≥ 3). 7. Rate their bladder condition as “Some Moderate Problems”, “Severe Problems”, or “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire at Baseline/Visit 2. 8. Able and willing to complete the micturition diaries and all trial related questionnaires, comply with scheduled clinic visits and clinical trial procedures. 9. Capability of understanding and having 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 |
Subjects presenting with any of the following will not be included in the trial: 1. Any condition that would contraindicate their usage of fesoterodine, including: • Hypersensitivity to the active substance (fesoterodine) 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 • toxic megacolon. 2. Documented significant hepatic or renal disease, defined as twice the upper limit of the reference ranges for serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine. 3. Neurologic conditions, such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease. 4. Stage 3 or greater pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure). 5. History of lower urinary tract surgery (e.g. incontinence surgery or surgery to reduce prostate size) within the past 6 months. 6. A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, radiation cystitis, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia. 7. Previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline. 8. Use of an indwelling catheter or an intermittent self-catheterization program. 9. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. 10. Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year. 11. Have started any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 1. 12. Previously treated with 3 or more antimuscarinic OAB medications within 12 months prior to screening [Note: any current treatment must stop at screening]; the antimuscarinic OAB medication may include: • darifenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium 13. Expectation of initiating treatment during the study with: • Any drug treatment for overactive bladder • Any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects 14. Intermittent or unstable use of diuretics throughout study duration. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted. 15. Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (i.e., ketoconazole, itraconazole), protease inhibitors, or the expectation to start such a treatment during the trial. 16. Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days. 17. Previously received any investigational drug within 30 days prior to study entry. 18. Previously participated in any fesoterodine clinical trial. 19. Alcohol and/or any other drug abuse in the opinion of the investigator. 20. Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study. 21. Female subjects of childbearing potential who are heterosexually active but not using an adequate form of contraception. Reliable contraceptive methods defined as intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide. 22. Subjects who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating. 23. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Percentage of subjects reporting satisfaction (including ‘very satisfied’ and ‘somewhat satisfied’) with their current OAB treatment using the Treatment Satisfaction Question at Week 12 • Change in mean number of micturition episodes per 24 hours at week 12 relative to baseline. • Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 12 relative to the baseline in subjects with a baseline of UUI ≥ 1 episode(s) during the 5-day urinary diary period. • Change in mean number of urgency episodes per 24 hours at week 12 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of ≥ 3 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 | 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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Possible increased dose in 2nd phase dependent on patient satisfaction/response to therapy |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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 |
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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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End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application and ethics application in the Member State. End of Trial in all participating countries is defined as Last Subject Last Visit. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |