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Trial record 1 of 1 for:    NCT00561951
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Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

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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:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 19, 2007
First Posted Date  ICMJE November 21, 2007
Results First Submitted Date  ICMJE January 11, 2010
Results First Posted Date  ICMJE September 9, 2010
Last Update Posted Date July 14, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History Complete list of historical versions of study NCT00561951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   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: August 18, 2010)
951
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2007)
900
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 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 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  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 Hong Kong,   Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00561951
Other Study ID Numbers  ICMJE A0221005
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 July 2011

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