E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stress urinary incontinence |
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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 | 10066218 |
E.1.2 | Term | Stress urinary incontinence |
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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 determine whether fesoterodine increases urethral tone relative to placebo in SUI patients. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the effect of fesoterodine on urethral function in SUI patients. • To evaluate the safety and tolerability of fesoterodine in SUI patients. • To explore efficacy of fesoterodine on diary related endpoints.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 2. Female outpatients aged 18 to 65 years. 3. Clinically significant stress urinary incontinence (SUI) presenting either as pure SUI, or as stress predominant mixed urinary incontinence (MUI) with history of symptoms greater than 3 months. Stress predominant MUI is defined as subject having a greater number of stress urinary incontinence episodes per week than urgency incontinence episodes. 4. Objective evidence of SUI (without concomitant evidence of detrusor over activity associated with urinary incontinence) as shown by either:Previous evidence of urodynamically proven SUI within 12 months of screening or during cystometry performed at the screening visit. 5. Subjects must be non-pregnant and non-lactating, and be either of non childbearing potential or must agree to use an acceptable form of contraception as detailed in the Life Style Guidelines. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary, and other trial procedures. |
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E.4 | Principal exclusion criteria |
1. Significant neurological disease or trauma. 2. Other severe acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator or Pfizer clinician, would make the subject inappropriate for entry into this trial. 3. Clinically significant abnormal 12-lead ECG taken at screening. 4. Malignancy within the past 2 years with the exception of basal cell carcinoma. 5. A history of febrile illness within 5 days prior to the first study period. 6. A history of lower urinary tract or pelvic surgery, with the exception of any minor surgery performed more than 3 months previously, which in the investigator’s opinion will not affect urethral tone. 7. A history or evidence of lower urinary tract anatomical anomaly, eg, clinically significant (grades >2) urogenital prolapse; urethral stricture. 8. History or evidence of urinary outlet obstruction or urinary retention, including post void residual volume >50 mL. 9. Passive urinary incontinence. 10. Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC). 11. Subjects who are incapable of independent toileting. 12. History of any form of irradiation to the pelvis. 13. Subjects who intend to start a bladder-training program or physiotherapy regimen during the study. 14. Subjects with greater than 1+ of haematuria on dipstick test, unless fully investigated prior to randomization to rule out significant urological disease. 15. Subjects with a documented and untreated urinary tract infection at screening. 16. Subjects with any condition which would contra-indicate the use of fesoterodine specifically, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, severe hepatic impairment, toxic megacolon. 17. Known hypersensitivity to fesoterodine, its excipients (including peanut or soya) or other antimuscarinics. 18. Subjects taking moderate or potent CYP3A4 inhibitors. 19. Creatinine clearance ≤30 mL/min. 20. Subjects with significant hepatic impairment. 21. Any condition possibly affecting drug absorption. 22. Subjects who are unable to swallow oral medication (tablets). 23. Use of prescription or non-prescription drugs known to have effects on lower urinary tract function within 14-days of study period 1 or during the study. 24. Subjects receiving pharmacotherapy for OAB or SUI. 25. Treatment with an investigational drug - within 30 days or 5 x half life preceeding study period. 26. History of illicit drug use or alcohol abuse in the last 12 months. 27. Intention to donate blood/blood products during the study or up to one month after completion of the study. 28. Subjects who in the opinion of the investigator, or that of the Pfizer clinician, are unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint • Urethral opening pressure.
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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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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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 | 12 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |