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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00658684
First received: April 9, 2008
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.


Condition Intervention Phase
Overactive Bladder
Drug: fesoterodine fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    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.


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

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ 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.

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 153
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine fumarate Drug: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 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 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.
  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: NCT00658684

Locations
Japan
Pfizer Investigational Site
Inegeku, Chibashi, Chiba-ken, Japan
Pfizer Investigational Site
Amagasaki-shi, Hyogo, Japan
Pfizer Investigational Site
Kaibara-cho, tanba-shi, Hyogo, Japan
Pfizer Investigational Site
Akashi-shi, Hyougo, Japan
Pfizer Investigational Site
Chuou-ku, koube-shi, Hyougo, Japan
Pfizer Investigational Site
Nishinomiya-shi, Hyougo, Japan
Pfizer Investigational Site
Kawasakishi, Kanagawaken, Japan
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Nara-shi, Nara, Japan
Pfizer Investigational Site
Osaka-shi, Osaka, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
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: NCT00658684     History of Changes
Other Study ID Numbers: A0221006, A0221006
Study First Received: April 9, 2008
Results First Received: July 14, 2010
Last Updated: October 5, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 29, 2014