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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

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: fesoterodine fumarate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 951 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : November 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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.


  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:

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561951


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Locations
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Hong Kong
Pfizer Investigational Site
Kowloon, Hong Kong
Pfizer Investigational Site
Shatin, Hong Kong
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Chuo-ku, Chiba-shi, Chiba-ken, Japan
Pfizer Investigational Site
Eiheiji-cyo,yoshida-gun,, Fukui-ken, Japan
Pfizer Investigational Site
Fukuoka-Shi, Fukuoka-Ken, Japan
Pfizer Investigational Site
Koga-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Minami-ku, Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Nishi-ku, Fukuoka, Japan
Pfizer Investigational Site
Sawara-ku, Fukuoka, Japan
Pfizer Investigational Site
Amagasaki-shi, Hyogo, Japan
Pfizer Investigational Site
Suma-ku, Kobe-shi, Hyogo, Japan
Pfizer Investigational Site
Higashinada, Hyougo, Japan
Pfizer Investigational Site
Nada-ku, Kobe-shi, Hyougo, Japan
Pfizer Investigational Site
Takaraduka-city, Hyougo, Japan
Pfizer Investigational Site
Aira-gun, Aira-chou,, Kagosima, Japan
Pfizer Investigational Site
Kawasakishi, Kanagawaken, Japan
Pfizer Investigational Site
Isogo-ku, Yokohama-shi, Kanagawa, Japan
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Tama-ku, Kawasaki-shi, Kanagawa, Japan
Pfizer Investigational Site
Kouchi-shi, Kouchi, Japan
Pfizer Investigational Site
Tamana-shi, Kumamoto-ken, Japan
Pfizer Investigational Site
Matumoto-Shi, Nagano-Ken, Japan
Pfizer Investigational Site
Matsumoto-shi, Nagano, Japan
Pfizer Investigational Site
Hunaki-cho, Ibaraki-shi, Osaka, Japan
Pfizer Investigational Site
Kita-ku, Osaka-shi, Osaka, Japan
Pfizer Investigational Site
Kosobe-cho, Takatsuki-shi, Osaka, Japan
Pfizer Investigational Site
Minami-ku, Sakai-shi, Osaka, Japan
Pfizer Investigational Site
Nishinari-ku, Osaka, Japan
Pfizer Investigational Site
Osaka-shi, Osaka, Japan
Pfizer Investigational Site
Suita-shi,, Osaka, Japan
Pfizer Investigational Site
Suita-shi, Osaka, Japan
Pfizer Investigational Site
Toyonaka-city, Osaka, Japan
Pfizer Investigational Site
Yodogawa-Ku, Osaka, Japan
Pfizer Investigational Site
Saitama-shi, Saitama-ken, Japan
Pfizer Investigational Site
Satte-shi, Saitama, Japan
Pfizer Investigational Site
Wakou-shi, Saitama, Japan
Pfizer Investigational Site
Gotenbashi, Shizuokaken, Japan
Pfizer Investigational Site
Susono, Shizuokaken, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chofu-shi, Tokyo, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Fucyushi, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Nishitokyo-shi, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Setgaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Suginami-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan
Pfizer Investigational Site
Chuou-shi, Yamanashi, Japan
Pfizer Investigational Site
Kumamoto, Japan
Korea, Republic of
Pfizer Investigational Site
Cheonan-si, Chungcheongnam-do, Korea, Republic of, 330-715
Pfizer Investigational Site
Pusan, Korea, Republic of, 602-739
Pfizer Investigational Site
Seoul, Korea, Republic of, 100-380
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Taiwan
Pfizer Investigational Site
Chiayi Country, Taiwan, 613
Pfizer Investigational Site
Hualien, Taiwan, 970
Pfizer Investigational Site
Koahsiung, Taiwan, 833
Pfizer Investigational Site
Taichung, Taiwan, 402
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taipei, Taiwan, 112
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00561951     History of Changes
Other Study ID Numbers: A0221005
First Posted: November 21, 2007    Key Record Dates
Results First Posted: September 9, 2010
Last Update Posted: July 14, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
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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
Physiological Effects of Drugs
Urological Agents