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

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

This study is currently recruiting participants.

Study NCT00561951. Last updated on November 3, 2008. Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]
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 ]

Condition ^†

Overactive Bladder

Intervention ^†

Drug: Placebo
Drug: fesoterodine fumarate

MEDLINE PMIDs

Links

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

900

Start Date ^†

November 2007

Completion Date

December 2008

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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

Hong Kong, Japan, Korea, Republic of, Taiwan

Administrative Information Fields

NCT ID ^†

NCT00561951

Organization ID

A0221005

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2008

First Received Date ^†

November 19, 2007

Last Updated Date

November 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.