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

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ClinicalTrials.gov Identifier: NCT01302067
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : December 24, 2013
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 18, 2011
First Posted Date  ICMJE February 23, 2011
Results First Submitted Date  ICMJE November 1, 2013
Results First Posted Date  ICMJE December 24, 2013
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
Change in mean number of urgency urinary incontinence episodes per 24 hours at week 12 relative to baseline [ Time Frame: Baseline, Week 12 ]
Change History Complete list of historical versions of study NCT01302067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. [ Time Frame: Week 4 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
  • Change in mean number of micturitions per 24 hours at weeks 4 and 12 relative to baseline [ Time Frame: Baseline, week 4, week 12 ]
  • 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 ]
  • Change in mean number of urgency urinary incontinence episodes per 24 hours at week 4 relative to baseline [ Time Frame: Baseline, week 4 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in Patient Perception of Bladder Condition (PPBC) at week 12 relative to baseline [ Time Frame: Baseline, week 12 ]
  • Change in Urgency Perception Scale at week 12 relative to baseline. [ Time Frame: Baseline, week 12 ]
  • Change in Overactive Bladder Questionnaire symptoms at week 12 relative to baseline [ Time Frame: Baseline, week 12 ]
  • Diary dry rate at weeks 4 and 12 [ Time Frame: Week 4, Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Fesoterodine 8mg
    Oral, 1 tablet per day, 12 weeks duration, 8mg/day
  • Drug: Fesoterodine 4mg
    Oral, 1 tablet per day, 12 weeks duration, 4mg/day
  • Drug: Placebo
    Oral, 1 tablet per day, 12 weeks duration
Study Arms  ICMJE
  • Experimental: Fesoterodine 8mg
    Intervention: Drug: Fesoterodine 8mg
  • Experimental: Fesoterodine 4mg
    Intervention: Drug: Fesoterodine 4mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2014)
2012
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)
1990
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Norway,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01302067
Other Study ID Numbers  ICMJE A0221095
EIGHT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP