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: February 25, 2014
Last verified: February 2014
  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:


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: Week 12 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Micturitions include episodes of voluntary micturition and episodes of UUI.

  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Micturitions include episodes of voluntary micturition and episodes of UUI.

  • Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Micturitions include episodes of voluntary micturition and episodes of UUI.

  • Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Micturitions include episodes of voluntary micturition and episodes of UUI.

  • Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    UUI episodes were defined as those with the 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.

  • Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    UUI episodes were defined as those with the 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.

  • Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    UUI episodes were defined as those with the 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.

  • Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. 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.

  • Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. 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.

  • Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. 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.

  • Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. 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 Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).

  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.

  • Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

  • Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

  • Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

  • 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. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

  • Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

  • Percentage of Participants Who Became Dry at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary

  • Percentage of Participants Who Became Dry at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.


Enrollment: 2012
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:
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
Results First Received: November 1, 2013
Last Updated: February 25, 2014
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 April 22, 2014