Fesoterodine Flexible Dose Study - Full Text View

Purpose

A flexible dose regimen of fesoterodine (4mg and 8mg) is efficacious (better than placebo) and well tolerated in subjects with overactive bladder after 12 weeks of treatment.

Condition	Intervention	Phase
Overactive Bladder	Drug: Fesoterodine Drug: Placebo	Phase III

Drug Information available for:

Fesoterodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:	A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in mean number of micturitions per 24 hours relative to baseline. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability based on adverse event reporting during the study. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
OAB symptom improvements measured by bladder diary, including changes from baseline on urinary frequency, urgency, urgency urinary incontinence. [ Time Frame: Weeks 2, 6 and 12 ] [ Designated as safety issue: No ]
Improvement on PROs including categorical and/or score changes from baseline in Patient Perception of Bladder Condition, Urgency Severity Scale, Patient Perception of Urgency Scale and Overactive Bladder Questionnaire. [ Time Frame: Weeks 2, 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	August 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine (Double-Blind): Experimental	Drug: Fesoterodine 4 mg tablets OD for 2 weeks, then either 4 mg or 8 mg tablets OD for 10 weeks
Placebo (Double-Blind): Placebo Comparator	Drug: Placebo Corresponding placebo tablets OD for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Overactive bladder symptoms for greater than or equal to 3 months.
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536484

Show 95 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221014, A0221014
First Received:	September 25, 2007
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00536484
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Overactive Bladder

Study placed in the following topic categories:

Signs and Symptoms

Urinary Bladder, Overactive

Urologic Diseases

Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00536484