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

NCT00561951 | Completed Phase 2 Results

• 1 other identifier: A0221005
• Study Type: interventional
• Target: 951
• Locations: 4 countries
• Sites: 65

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.

  Baseline to Weeks 2, 4, 8, and 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.

  Baseline to Week 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.

  Baseline to Weeks 2, 4, 8, and 12

• Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.

  Baseline to Week 12

• Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.

  Baseline to Weeks 2, 4, 8, and 12

Study Arms (3)

Fesoterodine fumarate 4 mg (Double-Blind)

EXPERIMENTAL

Drug: fesoterodine fumarate

Placebo (Double-Blind)

PLACEBO COMPARATOR

Drug: Placebo

Fesoterodine fumarate 8 mg (Double-Blind)

EXPERIMENTAL

Drug: fesoterodine fumarate

Interventions

fesoterodine fumarate DRUG

8mg tablets OD for 12 weeks

Fesoterodine fumarate 8 mg (Double-Blind)

Placebo DRUG

Corresponding placebo tablets OD for 12 weeks

Placebo (Double-Blind)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urgency urinary incontinence \>= 1 per day.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

Pfizer Investigational Site

Kowloon, Hong Kong

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Shatin, Hong Kong

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Nagoya, Aichi-ken, Japan

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Chuo-ku, Chiba-shi, Chiba, Japan

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Eiheiji-cyo,yoshida-gun,, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Koga-shi, Fukuoka, Japan

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Minami-ku, Fukuoka-shi, Fukuoka, Japan

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Nishiku, Fukuoka, Japan

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Sawara-ku, Fukuoka, Japan

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Amagasaki-shi, Hyōgo, Japan

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Higashinada, Hyōgo, Japan

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Nada-ku, Kobe-shi, Hyōgo, Japan

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Suma-ku, Kobe-shi, Hyōgo, Japan

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Takaraduka-city, Hyōgo, Japan

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Aira-gun, Aira-chou,, Kagoshima-ken, Japan

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Isogo-ku, Yokohama-shi, Kanagawa, Japan

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Kawasakishi, Kanagawa, Japan

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Sagamihara-shi, Kanagawa, Japan

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Tama-ku, Kawasaki-shi, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Tamana-shi, Kumamoto, Japan

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Matsumoto-shi, Nagano, Japan

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Matumoto-Shi, Nagano, Japan

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Hunaki-cho, Ibaraki-shi, Osaka, Japan

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Kita-ku, Osaka-shi, Osaka, Japan

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Kosobe-cho, Takatsuki-shi, Osaka, Japan

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Minami-ku, Sakai-shi, Osaka, Japan

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Nishinari-ku, Osaka, Japan

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Osaka, Osaka, Japan

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Suita-shi,, Osaka, Japan

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Suita-shi, Osaka, Japan

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Toyonaka, Osaka, Japan

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Yodogawa-Ku, Osaka, Japan

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Saitama-shi, Saitama, Japan

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Satte-shi, Saitama, Japan

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Wakou-shi, Saitama, Japan

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Gotenbashi, Shizuoka, Japan

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Susono, Shizuoka, Japan

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Bunkyo-ku, Tokyo, Japan

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Chofu-shi, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Fucyushi, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Nakano-ku, Tokyo, Japan

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Nishi-Tokyo-shi, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Setgaya-ku, Tokyo, Japan

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Shibuya-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Suginami-ku, Tokyo, Japan

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Sumida-ku, Tokyo, Japan

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Chuou-shi, Yamanashi, Japan

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Cheonan-si, Chungcheongnam-do, 330-715, South Korea

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Pusan, 602-739, South Korea

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Seoul, 100-380, South Korea

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Seoul, 136-705, South Korea

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Seoul, 138-736, South Korea

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Chiayi Country, 613, Taiwan

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Hualien City, 970, Taiwan

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Koahsiung, 833, Taiwan

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Taichung, 402, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 14, 2011
• Results First Posted: September 9, 2010

Record last verified: 2011-07

Locations

HK (2); KR (5); JP (52); TW (6)