A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00798434

Purpose

The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment.

It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: Placebo Drug: Fesoterodine fumarate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Numeric change of micturition-related urgency episodes per 24 hours relative to baseline [ Time Frame: weeks 12, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients who report their treatment has improved (Patient Treatment Benefit Scale) [ Time Frame: week 12, 24 ] [ Designated as safety issue: No ]
Change in Patient Perception of Bladder Condition (PPBC) [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in Patient Perception of Urgency Scale (PPUS) [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in scores from the selected items from Overactive Bladder Satisfaction Questionnaire (OAB-S) [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in Overactive Bladder Questionnaire (OAB-q) [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in mean number of severe micturition-related urgency episodes per 24 hours [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in mean number of micturitions per 24 hours [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in mean number of night-time micturitions per 24 hours [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in mean number of urgency urinary incontinence episodes per 24 hours [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
The percentage of patients who were incontinent at baseline and became dry [ Time Frame: weeks 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
Change in number of urinary incontinence pads, barrier creams and powder (for skin protection) used by subjects with incontinence. [ Time Frame: week 12, 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	790
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Active Comparator Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.	Drug: Placebo placebo administered orally in the morning or evening.
Fesoterodine: Active Comparator Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.	Drug: Fesoterodine fumarate Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female ≥65 years old.
Overactive bladder symptoms for at least 3 months prior to study start.
Eight or more micturitions per 24 hours as confirmed by diary records

Exclusion Criteria:

Predominant Stress Urinary Incontinence
Active or recurrent bladder infections
Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798434

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 59 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Pfizer )
Study ID Numbers:	A0221045
Study First Received:	November 25, 2008
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00798434 History of Changes
Health Authority:	United Kingdom: Newcastle and North Tyneside 1 Research Ethics Committe

Keywords provided by Pfizer:

Overactive bladder syndrome, fesoterodine, elderly, flexible dose regimen, urgency, frequency, urge urinary incontinence, anticholinergic, antimuscarinic

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Cholinergic Antagonists

Urologic Diseases
Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on September 10, 2009