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

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561951
• Other study ID #: A0221005
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2007
• Last updated: July 11, 2011
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• fesoterodine fumarate
8mg tablets OD for 12 weeks
• Placebo
Corresponding placebo tablets OD for 12 weeks
• fesoterodine fumarate
4mg tablets OD for 12 weeks

Locations

Country	Name	City	State
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Shatin
Japan	Pfizer Investigational Site	Aira-gun, Aira-chou,	Kagosima
Japan	Pfizer Investigational Site	Amagasaki-shi	Hyogo
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	Chuo-ku, Chiba-shi	Chiba-ken
Japan	Pfizer Investigational Site	Chuou-shi	Yamanashi
Japan	Pfizer Investigational Site	Eiheiji-cyo,yoshida-gun,	Fukui-ken
Japan	Pfizer Investigational Site	Fucyushi	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-Shi	Fukuoka-Ken
Japan	Pfizer Investigational Site	Gotenbashi	Shizuokaken
Japan	Pfizer Investigational Site	Higashinada	Hyougo
Japan	Pfizer Investigational Site	Hunaki-cho, Ibaraki-shi	Osaka
Japan	Pfizer Investigational Site	Isogo-ku, Yokohama-shi	Kanagawa
Japan	Pfizer Investigational Site	Kawasakishi	Kanagawaken
Japan	Pfizer Investigational Site	Kita-ku, Osaka-shi	Osaka
Japan	Pfizer Investigational Site	Koga-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Kosobe-cho, Takatsuki-shi	Osaka
Japan	Pfizer Investigational Site	Koto-ku	Tokyo
Japan	Pfizer Investigational Site	Kouchi-shi	Kouchi
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Matsumoto-shi	Nagano
Japan	Pfizer Investigational Site	Matumoto-Shi	Nagano-Ken
Japan	Pfizer Investigational Site	Minami-ku, Fukuoka-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Minami-ku, Sakai-shi	Osaka
Japan	Pfizer Investigational Site	Nada-ku, Kobe-shi	Hyougo
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Nakano-ku	Tokyo
Japan	Pfizer Investigational Site	Nishi-ku	Fukuoka
Japan	Pfizer Investigational Site	Nishinari-ku	Osaka
Japan	Pfizer Investigational Site	Nishitokyo-shi	Tokyo
Japan	Pfizer Investigational Site	Osaka-shi	Osaka
Japan	Pfizer Investigational Site	Sagamihara-shi	Kanagawa
Japan	Pfizer Investigational Site	Saitama-shi	Saitama-ken
Japan	Pfizer Investigational Site	Satte-shi	Saitama
Japan	Pfizer Investigational Site	Sawara-ku	Fukuoka
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	Suita-shi	Osaka
Japan	Pfizer Investigational Site	Suita-shi,	Osaka
Japan	Pfizer Investigational Site	Suma-ku, Kobe-shi	Hyogo
Japan	Pfizer Investigational Site	Sumida-ku	Tokyo
Japan	Pfizer Investigational Site	Susono	Shizuokaken
Japan	Pfizer Investigational Site	Takaraduka-city	Hyougo
Japan	Pfizer Investigational Site	Tama-ku, Kawasaki-shi	Kanagawa
Japan	Pfizer Investigational Site	Tamana-shi	Kumamoto-ken
Japan	Pfizer Investigational Site	Toyonaka-city	Osaka
Japan	Pfizer Investigational Site	Wakou-shi	Saitama
Japan	Pfizer Investigational Site	Yodogawa-Ku	Osaka
Korea, Republic of	Pfizer Investigational Site	Cheonan-si	Chungcheongnam-do
Korea, Republic of	Pfizer Investigational Site	Pusan
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Taiwan	Pfizer Investigational Site	Chiayi Country
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Koahsiung
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Hong Kong,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Mean Voided Volume Per Micturition at 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.	Baseline to Week 12	No
Secondary	Change From Baseline in Mean Voided Volume Per Micturition at 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.	Baseline to Weeks 2, 4, 8, and 12	No
Secondary	Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).	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.	Baseline to Week12	No
Secondary	Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at 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.	Baseline to Week 12	No
Secondary	Change From Baseline for Patient Perception of Bladder Condition (PPBC) at 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.	Baseline to Week 12	No
Secondary	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.	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	Baseline to Week 12	No

External Links

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