Clinical trial NCT00561951: Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 951
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
timeFrame: Baseline to Week12
measure: Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
timeFrame: Baseline to Week 12
measure: Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
timeFrame: Baseline to Week 12
measure: 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.
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Chuo-ku, Chiba-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba-ken
city: Eiheiji-cyo,yoshida-gun,
country: Japan
facility: Pfizer Investigational Site
state: Fukui-ken
city: Fukuoka-Shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-Ken
city: Koga-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Minami-ku, Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Nishi-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Sawara-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Amagasaki-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Suma-ku, Kobe-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Higashinada
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Nada-ku, Kobe-shi
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Takaraduka-city
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Aira-gun, Aira-chou,
country: Japan
facility: Pfizer Investigational Site
state: Kagosima
city: Kawasakishi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawaken
city: Isogo-ku, Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Tama-ku, Kawasaki-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Kouchi-shi
country: Japan
facility: Pfizer Investigational Site
state: Kouchi
city: Tamana-shi
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto-ken
city: Matumoto-Shi
country: Japan
facility: Pfizer Investigational Site
state: Nagano-Ken
city: Matsumoto-shi
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Hunaki-cho, Ibaraki-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kita-ku, Osaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kosobe-cho, Takatsuki-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Minami-ku, Sakai-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Nishinari-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suita-shi,
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suita-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Toyonaka-city
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Yodogawa-Ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Saitama-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama-ken
city: Satte-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Wakou-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Gotenbashi
country: Japan
facility: Pfizer Investigational Site
state: Shizuokaken
city: Susono
country: Japan
facility: Pfizer Investigational Site
state: Shizuokaken
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chofu-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fucyushi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nishitokyo-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setgaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuou-shi
country: Japan
facility: Pfizer Investigational Site
state: Yamanashi
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Cheonan-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Chungcheongnam-do
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Chiayi Country
country: Taiwan
facility: Pfizer Investigational Site
city: Hualien
country: Taiwan
facility: Pfizer Investigational Site
city: Koahsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: