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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00561951

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: fesoterodine fumarate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety measurement based on Adverse events, Vital signs, Clinical laboratory test, 12-lead ECG and Residual urine volume. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
The number of subjects shifted in Patient Perception of Bladder Condition (PPBC) responses from baseline to Week 12 assessment and its percentage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in mean number of micturitions, incontinence episodes, urgency episodes and nighttime micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Change from baseline in mean number of urgency urinary incontinence (UUI) episodes at Week 2, 4 and 8. [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
Change from baseline in score of King's Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in grade of PPBC at week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in mean voided volume per micturitions at Week 2, 4, 8 and 12. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	November 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine fumarate (Double-Blind): Experimental	Drug: fesoterodine fumarate 4 mg or 8mg tablets OD for 12 weeks
Placebo (Double-Blind): Placebo Comparator	Drug: Placebo Corresponding placebo tablets OD for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561951

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Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221005
Study First Received:	November 19, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00561951 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on November 27, 2009