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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

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ClinicalTrials.gov Identifier: NCT00658684
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : August 11, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 9, 2008
First Posted Date  ICMJE April 15, 2008
Results First Submitted Date  ICMJE July 14, 2010
Results First Posted Date  ICMJE August 11, 2010
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume [ Time Frame: 52 Weeks ]
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
To assess the long term safety, tolerability and efficacy of Fesoterodine. [ Time Frame: 52 Weeks ]
Change History Complete list of historical versions of study NCT00658684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
    Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
  • Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]
    KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement. KHQ consists of the following domains:
    • General health perceptions (GHP)
    • Impact on life
    • Role limitations
    • Physical limitations
    • Social limitations
    • Personal relationships (PR)
    • Emotions
    • Sleep/energy
    • Incontinence severity measures (ISM)
    Change: mean at Week 28 and 52 minus mean at Baseline
  • Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]
    OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement). Change: mean at Week 28 and 52 minus mean at baseline
  • The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage [ Time Frame: Week 28 and 52 ]
    The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:
    1. no problems at all
    2. some very minor problems
    3. some minor problems
    4. some moderate problems
    5. severe problems
    6. many severe problems
  • Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ]
    The PPBC assessment was rated on a 6-point scale as follows:
    1. no problems at all
    2. some very minor problems
    3. some minor problems
    4. some moderate problems
    5. severe problems
    6. many severe problems
    Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
  • Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]
  • Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 52 weeks ]
  • Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52. [ Time Frame: Week 28 and 52 ]
  • The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 28 and 52 assessment and its percentage. [ Time Frame: Week 28 and 52 ]
  • Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ]
  • Change from baseline in mean number of micturitions, urgency urinary incontinence (UUI) episodes, incontinence episodes, urgency episodes and nighttime micturitions at Week 4, 8, 28 and 52. [ Time Frame: Week 4, 8, 28 and 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Official Title  ICMJE An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
Brief Summary To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE Drug: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Study Arms  ICMJE Experimental: Fesoterodine fumarate
Intervention: Drug: fesoterodine fumarate
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: September 29, 2009)
153
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
150
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

Exclusion Criteria:

  • Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
  • Patient has a known neurological disease influencing bladder function.
  • Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658684
Other Study ID Numbers  ICMJE A0221006
A0221006
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 October 2010

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