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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

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ClinicalTrials.gov Identifier: NCT00611026
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 12, 2011
Last Update Posted : February 2, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 28, 2008
First Posted Date  ICMJE February 8, 2008
Results First Submitted Date  ICMJE October 12, 2010
Results First Posted Date  ICMJE January 12, 2011
Last Update Posted Date February 2, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 [ Time Frame: Baseline, Week 12 ]
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in subjects with overactive bladder [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
  • Change From Baseline in Mean Voided Volume Per Micturition [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
  • Percent Change From Baseline of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).
  • Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
  • Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 [ Time Frame: Baseline, Week 1, Week 4 ]
    UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Percent Change From Baseline of UUI Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
  • Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
  • Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary [ Time Frame: Week 1, Week 4, Week 12 ]
    Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
  • Change From Baseline in Patient Perception of Bladder Condition (PPBC) [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ]
    Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
  • Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ]
    Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    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. Negative change in Symptom Bother Score indicates improvement.
  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 [ Time Frame: Baseline, Week 12 ]
    HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
  • To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder [ Time Frame: 12 weeks ]
  • To compare the efficacy of fesoterodine 4 mg QD with that of placebo in subjects with overactive bladder [ Time Frame: 1 week ]
  • To summarize safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
Official Title  ICMJE 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.
Brief Summary To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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: Tolterodine ER
    The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
  • Drug: Placebo
    Placebo treatment will be once daily(QD) for 12 weeks.
  • Drug: Fesoterodine
    The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Tolterodine ER
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 3
    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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2010)
2417
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2008)
1675
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
  • Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

  • Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
  • Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
  • Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
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 Brazil,   Bulgaria,   Canada,   Colombia,   Costa Rica,   Estonia,   Germany,   Greece,   Hungary,   India,   Ireland,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00611026
Other Study ID Numbers  ICMJE A0221046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

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