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A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

NCT ID: NCT00425100

Last Updated: 2018-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

Brief Summary

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To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label-fesoterodine

Single treatment study arm.

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

Interventions

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fesoterodine fumarate

12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
* OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion Criteria

* Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Homewood, Alabama, United States

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Huntsville, Alabama, United States

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La Mesa, California, United States

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Orangevale, California, United States

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Aurora, Colorado, United States

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West Palm Beach, Florida, United States

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Aurora, Illinois, United States

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Pratt, Kansas, United States

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Shreveport, Louisiana, United States

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Milford, Massachusetts, United States

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Omaha, Nebraska, United States

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Woodlane, New Jersey, United States

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Kingston, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Bethany, Oklahoma, United States

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Eugene, Oregon, United States

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Sellersville, Pennsylvania, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Milwaukee, Wisconsin, United States

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Jette, , Belgium

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Turnhout, , Belgium

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Alajuela Centro, Alajuela Province, Costa Rica

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San José, , Costa Rica

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Brno-Bohunice, , Czechia

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Hradec Králové, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Alzey, , Germany

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Berlin, , Germany

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Duisburg, , Germany

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Frankfurt, , Germany

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Marburg, , Germany

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Muelheim A.d. Ruhr, , Germany

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München, , Germany

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Lodz, , Poland

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Mysłowice, , Poland

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Bratislava, , Slovakia

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Malacky, , Slovakia

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Piešťany, , Slovakia

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Prešov, , Slovakia

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Skalica, , Slovakia

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Bucheon-si, Gyunggi-do, South Korea

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Busan, , South Korea

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Daejeon, , South Korea

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Jeonnam, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Chernivtsi, , Ukraine

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Dnipropetrovsk, , Ukraine

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Kharkiv, , Ukraine

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Odesa, , Ukraine

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Pfizer Investigational Site

Zaporizhzhia, , Ukraine

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Countries

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United States Belgium Costa Rica Czechia Germany Poland Slovakia South Korea Ukraine

References

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Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.

Reference Type DERIVED
PMID: 19348029 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221007&StudyName=A%20Clinical%20Trial%20To%20Assess%20Fesoterodine%20On%20Treatment%20Satisfaction%20And%20Symptom%20Improvement%20In%20Overactive%20Bladder%20Patients

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

Other Identifiers

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A0221007

Identifier Type: -

Identifier Source: org_study_id

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