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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00561951
First received: November 19, 2007
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.


Condition Intervention Phase
Overactive Bladder
Drug: fesoterodine fumarate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Enrollment: 951
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine fumarate 4 mg (Double-Blind) Drug: fesoterodine fumarate
4mg tablets OD for 12 weeks
Placebo Comparator: Placebo (Double-Blind) Drug: Placebo
Corresponding placebo tablets OD for 12 weeks
Experimental: Fesoterodine fumarate 8 mg (Double-Blind) Drug: fesoterodine fumarate
8mg tablets OD for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561951

  Show 65 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00561951     History of Changes
Other Study ID Numbers: A0221005
Study First Received: November 19, 2007
Results First Received: January 11, 2010
Last Updated: July 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014