Fesoterodine Flexible Dose Study - Full Text View

Purpose

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Condition	Intervention	Phase
Overactive Bladder	Drug: Fesoterodine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2 and Week 6 ] [ Designated as safety issue: No ]
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ] [ Designated as safety issue: No ]

Enrollment:	896
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
Experimental: Fesoterodine (Double-Blind)	Drug: Fesoterodine 4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Placebo Comparator: Placebo (Double-Blind)	Drug: Placebo Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

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

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:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00536484 History of Changes
Other Study ID Numbers:	A0221014
Study First Received:	September 25, 2007
Results First Received:	March 12, 2009
Last Updated:	September 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Overactive Bladder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on June 17, 2013