A study to confirm the effectiveness of 8mg of fesoterodine compared to 4mg fesoterodine in subjects with overactive bladder

• Conditions: Overactive Bladder; MedDRA version: 14.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2010-024181-22-BG
• Lead Sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-01
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1990

Inclusion Criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
At Screening V1
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Male or female subjects aged =18.
3. Overactive bladder symptoms (subject-reported) for =6 months prior to screening/Visit 1 according to ICS guidelines.
4. Rate their bladder condition as Some Moderate Problems”, Severe Problems”, or
Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC)
questionnaire.
5. Female subjects must not be pregnant, nursing, or have a positive urine pregnancy test or be intending to become pregnant within 3 months after the completion of the trial. Female subjects of childbearing potential who are heterosexually active must 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
6. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities.
In addition at V2
7. Mean urinary frequency of =8 micturitions per 24 hours as verified by 3-day bladder
diary prior to Visit 2.
8. Mean of between =2 UUI and = 15 UUI episodes per day as verified by 3-day bladder diary prior to Visit 2 [defined as those micturitions with Urinary Sensation Scale rating of 5 in the diary].
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. Any condition that would contraindicate their use of fesoterodine including:
hypersensitivity to 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.
3. Conditions or prior treatment that may also affect bladder function:
a. Neurologic conditions such as spinal dysraphism, stroke, multiple sclerosis, spinal
cord injury, or Parkinson’s disease, which are known or suspected of influencing the
subject’s bladder function.
b. Significant pelvic organ prolapse defined as tissue visible through introitus in
lithotomy position at rest (without increase in intra abdominal pressure).
c. Symptoms of incontinence being predominately stress urinary incontinence as
determined by the investigator.
d. Any history of major lower urinary tract/pelvic surgery with permanent or ongoing
effects on bladder function.
e. A known history of interstitial cystitis/bladder pain syndrome 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, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter
dyssynergia.
f. Bladder outlet obstruction evidenced by previous history of acute urinary retention
requiring catheterization, use of an indwelling catheter or an intermittent
self-catheterization program, urodynamic evidence of obstruction or severe voiding
symptoms including a previously measured post-void residual volume of > 200 ml
which has not subsequently been appropriately managed.
4. Clinically significant urinary tract infection (UTI) as shown by the results of the
urinalysis at Screening or Randomization or recurrent urinary tract infection (RUTIs)
defined as microbiologically proven UTI >3 times in the last year or >2 times in the last 6 months. Urine microscopy, culture and sensitivity testing will be performed in the event of symptoms (eg, fever, dysuria), or positive leucocytes, nitrites and/or protein on urinalysis. Re-screening may be performed when the UTI has been treated and urine is culture negative, assuming the subject does not meet the definition for recurrent UTI.
5. Initiation of: electrostimulation, 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; subjects who are already established on stable therapy should continue with their regimen at a stable level through the course of the study.
6. Treatment with the following drugs as specified below:
a. Treatment with intra-vesical Botulinum toxin within 6 months of Visit 1.
b. Any other drugs with significant anticholinergic and antispasmodic effects (these
must be discontinued for a minimum of 2 weeks prior to Visit 1 except solifenacin
which should be discontinued for a minimum of 3 weeks prior to Visit 1).
c. Has started treatment with tricyclic antidepressants or estrogens within 4 weeks of Visi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified