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Completed

NCT Number: NCT00658684

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

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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Inegeku, Chibashi, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fesoterodine fumarate

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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:

    • no problems at all
    • some very minor problems
    • some minor problems
    • some moderate problems
    • severe problems
    • many severe problems

  10. 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:

    • no problems at all
    • some very minor problems
    • some minor problems
    • some moderate problems
    • severe problems
    • many severe problems

    Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2008
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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