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

• 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: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: April 9, 2008
• First Posted Date: April 15, 2008
• Results First Submitted Date: July 14, 2010
• Results First Posted Date: August 11, 2010
• Last Update Posted Date: October 13, 2010
• Study Start Date: February 2008
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 14, 2008): To assess the long term safety, tolerability and efficacy of Fesoterodine. [ Time Frame: 52 weeks ]

Current Secondary Outcome Measures (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 (submitted: April 14, 2008)

• Change from baseline in mean voided volume per micturitions at Week 4, 8, 28 and 52. [ Time Frame: Weeks 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: Weeks 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: Weeks 28 and 52 ]
• Change from baseline in grade of PPBC at Week 28 and 52. [ Time Frame: Weeks 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: Weeks 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: Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Overactive Bladder

Intervention

Drug: fesoterodine fumarate

4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Study Arms

Experimental: Fesoterodine fumarate

Intervention: Drug: fesoterodine fumarate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2009): 153
• Original Estimated Enrollment (submitted: April 14, 2008): 150
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 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: Japan

Administrative Information

• NCT Number: NCT00658684
• Other Study ID Numbers: A0221006; A0221006
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2010