Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine ER in Patients With Overactive Bladder. - Full Text View

Purpose

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

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

ChemIDplus related topics:

Tolterodine Fesoterodine Tolterodine tartrate

U.S. FDA Resources

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

Official Title:	12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To compare the efficacy of fesoterodine 4 mg QD with that of placebo in subjects with overactive bladder [ Time Frame: 1 week ] [ Designated as safety issue: No ]
To summarize safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1675
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator	Drug: Placebo Placebo treatment will be QD for 12 weeks.
3: Experimental	Drug: Fesoterodine The fesoterodine treatment will start with 4 mg QD for 1 week followed by a forced dose-escalation to 8mg QD for 11 weeks.
1: Active Comparator	Drug: Tolterodine ER The tolterodine treatment will be 4 mg QD for 12 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (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.
Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611026

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 181 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:	A0221046
First Received:	January 28, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00611026
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Treatment of overactive bladder

Study placed in the following topic categories:

Signs and Symptoms

Urinary Bladder, Overactive

Urologic Diseases

Urinary Bladder Diseases

Tolterodine

Additional relevant MeSH terms:

Muscarinic Antagonists

Urological Manifestations

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Physiological Effects of Drugs

Cholinergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00611026