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

This study is currently recruiting participants.
Verified by Pfizer, September 2008

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

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  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




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