A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED CROSSOVER STUDY OF THE EFFICACY OF FESOTERODINE IN INCREASING URETHRAL PRESSURE IN STRESS URINARY INCONTINENCE PATIENTS

• Register: EUCTR
• Last refreshed on: 14 November 2016
• Main ID: EUCTR2008-005350-21-DK
• Date of registration: 07/01/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
• Public title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED CROSSOVER STUDY OF THE EFFICACY OF FESOTERODINE IN INCREASING URETHRAL PRESSURE IN STRESS URINARY INCONTINENCE PATIENTS
• Scientific title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED CROSSOVER STUDY OF THE EFFICACY OF FESOTERODINE IN INCREASING URETHRAL PRESSURE IN STRESS URINARY INCONTINENCE PATIENTS
• Date of first enrolment: 03/02/2009
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005350-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Stress urinary incontinence
MedDRA version: 9.1 Level: LLT Classification code 10066218 Term: Stress urinary incontinence

Intervention(s)

Trade Name: Toviaz
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-08
Other descriptive name: Fesoterodine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Toviaz
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-08
Other descriptive name: Fesoterodine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: • 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.

Primary end point(s): Primary Endpoint
• Urethral opening pressure.

Main Objective: • To determine whether fesoterodine increases urethral tone relative to placebo in SUI patients.

Secondary ID(s)

A0221064