Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00561951

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: fesoterodine fumarate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 12 assessment and its percentage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in mean number of micturitions, incontinence episodes, urgency episodes and nighttime micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Change from baseline in mean number of urgency urinary incontinence (UUI) episodes at Week 2, 4 and 8. [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in grade of PPBC at week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in mean voided volume per micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Fesoterodine fumarate (Double-Blind): Experimental	Drug: fesoterodine fumarate 4 mg or 8mg tablets OD for 12 weeks
Placebo (Double-Blind): Placebo Comparator	Drug: Placebo Corresponding placebo tablets OD for 12 weeks

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
Patient has a known neurological disease influencing bladder function.
Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561951

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:	A0221005
Study First Received:	November 19, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00561951 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on November 30, 2009