Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

• ClinicalTrials.gov Identifier: NCT00561951
• Recruitment Status: Completed
• First Posted: November 21, 2007
• Results First Posted: September 9, 2010
• Last Update Posted: July 14, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: November 19, 2007
• First Posted Date: November 21, 2007
• Results First Submitted Date: January 11, 2010
• Results First Posted Date: September 9, 2010
• Last Update Posted Date: July 14, 2011
• Study Start Date: November 2007
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2010)

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.

• Original Primary Outcome Measures (submitted: November 19, 2007): To assess the efficacy of fesoterodine 4 mg and 8 mg as compared to placebo in subjects with overactive bladder syndrome after 12 weeks of treatment and to determine the recommended dose in subjects with OAB.

Current Secondary Outcome Measures (submitted: February 15, 2011)

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
  Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
  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. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  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. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
  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. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  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. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
  Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Mean Voided Volume Per Micturition at Week 12. [ Time Frame: Baseline to Week 12 ]
  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. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
  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. Change: mean at each visit minus mean at Baseline.
• Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). [ Time Frame: Baseline to Week12 ]
  King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Baseline to Week 12 ]
  The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
• Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]
  Patient Perception of Bladder Condition (PPBC) score is 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 12 minus mean at Baseline.
• The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]
  Patient Perception of Bladder Condition (PPBC) score is 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

Original Secondary Outcome Measures (submitted: November 19, 2007)

• To assess the safety and tolerability of fesoterodine 4 mg and 8 mg as compared to placebo in subjects with OAB after 12 weeks of treatment.
• To investigate pharmacokinetics of 5-hydroxymethyl tolterodine (SPM7605), active metabolite of fesoterodine in patients with OAB who take fesoterodine 4 mg and 8 mg at weeks 4 and 12.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
• Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
• Brief Summary: To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Overactive Bladder

Intervention

• Drug: fesoterodine fumarate
  8mg tablets OD for 12 weeks
• Drug: Placebo
  Corresponding placebo tablets OD for 12 weeks
• Drug: fesoterodine fumarate
  4mg tablets OD for 12 weeks

Study Arms

• Experimental: Fesoterodine fumarate 4 mg (Double-Blind)
  Intervention: Drug: fesoterodine fumarate
• Placebo Comparator: Placebo (Double-Blind)
  Intervention: Drug: Placebo
• Experimental: Fesoterodine fumarate 8 mg (Double-Blind)
  Intervention: Drug: fesoterodine fumarate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 18, 2010): 951
• Original Estimated Enrollment (submitted: November 19, 2007): 900
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 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 urgency urinary incontinence >= 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: Hong Kong, Japan, Korea, Republic of, Taiwan

Administrative Information

• NCT Number: NCT00561951
• Other Study ID Numbers: A0221005
• 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: Not Provided
• 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: July 2011