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Completed

NCT Number: NCT00561951

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

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

Completed

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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 2

Primary location

Pfizer Investigational Site, Kowloon, Hong Kong

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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 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.

Treatment and study plan

fesoterodine fumarate

Drug

8mg tablets OD for 12 weeks

Placebo

Drug

Corresponding placebo tablets OD for 12 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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:

    • No problems at all
    • Some very minor problems
    • Some minor problems
    • Some moderate problems
    • Severe problems
    • Many severe problems

    Change: mean at Week 12 minus mean at Baseline.

  15. 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:

    • No problems at all
    • Some very minor problems
    • Some minor problems
    • Some moderate problems
    • Severe problems
    • Many severe problems

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2007
Registry last updated
Jul 14, 2011

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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