A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00911937

Purpose

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Resource links provided by NLM:

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 related nocturnal urgency episodes per 24 hours at Treatment Week 12 relative to baseline (defined as those with Urinary Sensation Scale rating of >=3 and recorded in the bed time section of the bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
diary). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bladder Diary [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
Overactive Bladder Questionnaire (OAB q) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety Evaluations [ Time Frame: 2, 4 and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	963
Study Start Date:	August 2009
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fesoterodine	Drug: Fesoterodine Fesoterodine 4mg and 8 mg tablets taken daily.
Placebo Comparator: Placebo	Drug: Placebo Placebo sham 4mg and 8 mg tables taken daily.

Eligibility

Criteria

Inclusion Criteria:

Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911937

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00911937 History of Changes
Other Study ID Numbers:	A0221048
Study First Received:	June 1, 2009
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

incontinence OAB urgency nocturia

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 09, 2012