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Clinical Trials/NCT01302067
NCT01302067CompletedPhase 4

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.

Pfizer277 sites in 1 country2,012 target enrollmentStarted: May 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Pfizer
Enrollment
2,012
Locations
277
Primary Endpoint
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Fesoterodine 8mg

Experimental

Intervention: Fesoterodine 8mg (Drug)

Fesoterodine 4mg

Experimental

Intervention: Fesoterodine 4mg (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.

Time Frame: Week 12

UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Secondary Outcomes

  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.(Week 12)
  • Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.(Week 4)
  • Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.(Week 12)
  • Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.(Week 12)
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.(Week 4)
  • Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.(Week 4)
  • Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.(Week 12)
  • Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.(Week 4)
  • Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.(Week 12)
  • Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.(Week 12)
  • Percentage of Participants Who Became Dry at Week 12.(Week 12)
  • Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.(Week 4)
  • Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.(Week 12)
  • Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.(Week 12)
  • Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.(Week 12)
  • Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.(Week 12)
  • Percentage of Participants Who Became Dry at Week 4.(Week 4)
  • Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.(Week 12)
  • Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.(Week 4)
  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.(Week 12)
  • Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.(Week 12)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (277)

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