| 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. |
|
| 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 |
|
| 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 compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in
subjects with overactive bladder, after 12 weeks of treatment. |
|
| E.2.2 | Secondary objectives of the trial |
• To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder, after 12 weeks of treatment
• To compare the efficacy of fesoterodine 4mg QD with that of placebo in subjects with overactive bladder, after 1 week of treatment
• To summarize safety data for 12 weeks of treatment with either fesoterodine,
tolterodine ER, or placebo in subjects with overactive bladder |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male or female outpatients ≥18 years old;
2. Overactive bladder symptoms (subject-reported) for ≥3 months prior to Screening/Enrollment visit (Visit 1);
3. Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder
diary prior to the Randomization/Baseline visit (Visit 2);
4. Mean urinary frequency of ≥8 micturitions per 24 hours as verified by the 3-day
bladder diary prior to Randomization/Baseline visit (Visit 2);
5. Able and willing to complete the bladder diaries and all trial related questionnaires
and comply with scheduled clinic visits and clinical trial procedures;
6. 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. |
|
| 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. Clinically significant hepatic or renal disease, and/or with a screening test of AST, ALT, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal (ULN).
3. Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease, which are known or suspected of influencing the subject’s bladder function.
4. Significant 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/pelvic surgery (eg, surgery for incontinence, prolapse, or benign prostate hyperplasia, hysterectomy) 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. Has polyuria (>3000mL/24h) or a voided volume >500mL for any micturition during the run-in period.
11. 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.
12. Use of any electrostimulation, participation in a formal program of bladder training, or pelvic floor exercises under the supervision of a physician or other medical provider within 4 weeks of Visit 1.
13. Received study medication in any previous fesoterodine clinical trial.
14. Treated with the following drugs within 2 weeks prior to Visit 1:
• Any drug treatment for overactive bladder, including antimuscarinic OAB medications;
• Any drugs with significant anticholinergic and antispasmodic effects.
15. Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Visit 1 and/or is not on a stable dose.
16. Has started treatment with diuretics or alpha blockers within 2 weeks prior to Visit 1 and/or is not on a stable dose.
17. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 1.
18. Administration of medications capable of inducing hepatic enzyme metabolism or transport (eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days.
19. Previously received any investigational drug within 30 days prior to trial entry.
20. Alcohol and/or any other drug abuse in the opinion of the investigator.
21. Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 3 months after the completion of the trial.
22. Female subjects of childbearing potential who are heterosexually active but unwilling or unable to use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide.
23. 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 trial, or those who may increase the risk to themselves or others by participating.
24. Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours
at week 12 relative to the baseline (UUI episodes are defined as those micturitions
with Urinary Sensation Scale rating of 5 in the diary). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| 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) | 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 | Yes |
| E.8.1.7.1 | Other trial design description |
|
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 90 |
| 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 | 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
| |
| 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 | 1 |
| E.8.9.1 | In the Member State concerned days | 15 |
| 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 | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 15 |
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