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

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

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

Drug Information available for: Tolterodine Fesoterodine fumarate Fesoterodine Tolterodine tartrate

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
1: Active Comparator	Drug: Tolterodine ER The tolterodine treatment will be 4 mg QD for 12 weeks.
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.

Eligibility

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221046
Study First Received:	January 28, 2008
Last Updated:	January 9, 2009
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
Cystocele

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 January 16, 2009