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A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302067
First received: February 18, 2011
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.


Condition Intervention Phase
Overactive Bladder
 Drug: Fesoterodine 8mg
Drug: Fesoterodine 4mg
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in mean number of urgency urinary incontinence episodes per 24 hours at week 12 relative to baseline [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean number of micturitions per 24 hours at weeks 4 and 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
  • Percentage change in mean number of micturitions per 24 hours at weeks 4 and 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
  • Change in mean number of urgency urinary incontinence episodes per 24 hours at week 4 relative to baseline [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
  • Percentage change in mean number of urgency urinary incontinence episodes per 24 hours at week 4 and week 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
  • Change in mean number of micturition-related urgency episodes per 24 hours at weeks 4 and 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
  • Percentage change in mean number of micturition-related urgency episodes per 24 hours at weeks 4 and 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]
  • Change in Patient Perception of Bladder Condition (PPBC) at week 12 relative to baseline [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  • Change in Urgency Perception Scale at week 12 relative to baseline. [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  • Change in Overactive Bladder Questionnaire symptoms at week 12 relative to baseline [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  • Diary dry rate at weeks 4 and 12 [ Time Frame: Week 4, Week 12 ] [ Designated as safety issue: No ]

Enrollment: 3659
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine 8mg Drug: Fesoterodine 8mg
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
Experimental: Fesoterodine 4mg Drug: Fesoterodine 4mg
Oral, 1 tablet per day, 12 weeks duration, 4mg/day
Placebo Comparator: Placebo Drug: Placebo
Oral, 1 tablet per day, 12 weeks duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

  • Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302067

  Show 293 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302067     History of Changes
Other Study ID Numbers: A0221095, EIGHT
Study First Received: February 18, 2011
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013