Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00444925

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: fesoterodine fumarate Drug: placebo Drug: tolterodine tartrate	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, Efficacy Study
Official Title:	12-Week, 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:

Efficacy of fesoterodine in comparison to placebo and tolterodine ER for overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of fesoterodine in comparison to placebo for overactive bladder. [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
Effect of fesoterodine in comparison to placebo on patient reported outcomes in subjects with overactive bladder. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1700
Study Start Date:	April 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine: Experimental Tablets	Drug: fesoterodine fumarate 4 mg OD for 1 week followed by a forced dose-escalation to 8 mg OD for 11 weeks
Placebo: Placebo Comparator Tablets and capsules	Drug: placebo OD for 12 weeks
Tolterodine: Active Comparator Capsules	Drug: tolterodine tartrate 4 mg OD for 12 weeks

Eligibility

Criteria

Inclusion Criteria:

Adult OAB patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444925

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:	A0221008
Study First Received:	March 6, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00444925
Health Authority:	United States: Food and Drug Administration

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