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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 has been completed.
First Received: November 19, 2007   Last Updated: February 9, 2009   History of Changes
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:


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Show 66 Study Locations
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