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Trial record 1 of 1 for:    NCT01260311
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Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

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ClinicalTrials.gov Identifier: NCT01260311
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 22, 2010
First Posted Date December 15, 2010
Results First Submitted Date September 4, 2014
Results First Posted Date September 11, 2014
Last Update Posted Date September 11, 2014
Study Start Date February 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2014)
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment [ Time Frame: Baseline up to 28 days after last dose ]
Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).
Original Primary Outcome Measures
 (submitted: December 13, 2010)
  • Number of participants with adverse events as a measure of safety. [ Time Frame: Week 4 and 8 visit. ]
  • Number of micturitions per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ]
  • Number of urgency episodes per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ]
  • Number of urgency urinary incontinence (UUI) episodes per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ]
  • Patient perception of bladder condition as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2014)
  • Number of Micturitions Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ]
    Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
  • Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ]
    Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. 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.
  • Number of UUI Episodes Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ]
    UUI episodes were defined as those with 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.
  • Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ]
    PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
Official Title Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
Brief Summary This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
Detailed Description Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with Over-active bladder
Condition Over Active Bladder
Intervention Drug: Fesoterodine
Any dose of Fesoterodine
Other Name: Toviaz
Study Groups/Cohorts Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
Intervention: Drug: Fesoterodine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 11, 2013)
508
Original Estimated Enrollment
 (submitted: December 13, 2010)
3000
Actual Study Completion Date October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion Criteria:

  • Hypersensitivity
  • Urinary retention
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01260311
Other Study ID Numbers A0221085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2014