Fesoterodine "Add-on" Male Overactive Bladder Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00546637

Purpose

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Condition	Intervention	Phase
Overactive Bladder Syndrome	Drug: Fesoterodine Drug: Placebo	Phase III

MedlinePlus related topics: Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Numeric change of micturition-related urgency episodes per 24 hours at Week 12 relative to baseline. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OAB symptom improvements measured by bladder diary, including changes on urinary frequency, urgency, urgency urinary incontinence at Week 4, 8 and 12 from the baseline. [ Time Frame: week 4, 8 & 12 ] [ Designated as safety issue: No ]
Changes on International Prostate Symptom Score (IPSS) measurements, including total score, storage domain, voiding domain, quality-of-life score at Week 4, 8 and 12 from baseline. [ Time Frame: week 4, 8 & 12 ] [ Designated as safety issue: No ]
Post void residual urine volume changes from baseline at W4, 8 and 12; [ Time Frame: week 4, 8 & 12 ] [ Designated as safety issue: Yes ]
Qmax changes from baseline at W12; [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
Incidences of acute urinary retention requiring catheterization and incidences of adverse events related to increased voiding difficulty. [ Time Frame: any time during study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	900
Study Start Date:	November 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine 4mg or 8mg: Experimental	Drug: Fesoterodine Fesoterodine 4mg or 8mg
Placebo: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Criteria

Inclusion Criteria:

Men aged 40 years and above.
On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546637

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer,Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221009
Study First Received:	October 18, 2007
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00546637 History of Changes
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
Adrenergic alpha-Antagonists

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Pathologic Processes

Disease
Urologic Diseases
Syndrome
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 07, 2009