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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: fesoterodine fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Number of Micturition Episodes Per 24 Hours

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

Mean Number of Urgency Episodes Per 24 Hours

Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment

Secondary outcome:

Nocturnal Micturitions Per 24 Hours

Severe Urgency Episodes Per 24 Hours

Mean Rating on the Urinary Sensation Scale

Patient Perception of Bladder Condition (PPBC) Score

Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)

Urgency Perception Scale (UPS)

Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)

Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain

Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain

Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain

Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain

Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale

Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale

"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)

Sum Rating on the Urinary Sensation Scale

Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Bruxelles B-1200, Belgium

Pfizer Investigational Site, Edegem B-2650, Belgium

Pfizer Investigational Site, Gent B-9000, Belgium

Pfizer Investigational Site, Jette B-1090, Belgium

Pfizer Investigational Site, Turnhout B-2300, Belgium

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Brno-Bohunice 625 00, Czech Republic

Pfizer Investigational Site, Hradec Kralove 500 05, Czech Republic

Pfizer Investigational Site, Praha 2 128 08, Czech Republic

Pfizer Investigational Site, Praha 5 152 00, Czech Republic

Pfizer Investigational Site, Alzey 55232, Germany

Pfizer Investigational Site, Berlin 13347, Germany

Pfizer Investigational Site, Duisburg 47179, Germany

Pfizer Investigational Site, Frankfurt 65929, Germany

Pfizer Investigational Site, Marburg 35039, Germany

Pfizer Investigational Site, Muelheim a.d. Ruhr 45468, Germany

Pfizer Investigational Site, Muenchen 81925, Germany

Pfizer Investigational Site, Busan 602-739, Korea, Republic of

Pfizer Investigational Site, Daejeon 301-721, Korea, Republic of

Pfizer Investigational Site, Jeonnam 519-809, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of

Pfizer Investigational Site, Lodz 93-316, Poland

Pfizer Investigational Site, Myslowice 41-400, Poland

Pfizer Investigational Site, Bratislava 833 05, Slovakia

Pfizer Investigational Site, Malacky 901 01, Slovakia

Pfizer Investigational Site, Piestany 921 01, Slovakia

Pfizer Investigational Site, Presov 080 01, Slovakia

Pfizer Investigational Site, Skalica 909 82, Slovakia

Pfizer Investigational Site, Chernivtsi 58002, Ukraine

Pfizer Investigational Site, Dnipropetrovsk 49005, Ukraine

Pfizer Investigational Site, Kharkiv 61037, Ukraine

Pfizer Investigational Site, Odessa 65000, Ukraine

Pfizer Investigational Site, Zaporizhzhia 69000, Ukraine

Pfizer Investigational Site, Homewood, Alabama 35209, United States

Pfizer Investigational Site, Huntsville, Alabama 35801, United States

Pfizer Investigational Site, Alajuela Centro, Alajuela, Costa Rica

Pfizer Investigational Site, La Mesa, California 91942, United States

Pfizer Investigational Site, Orangevale, California 95662, United States

Pfizer Investigational Site, Aurora, Colorado 80012, United States

Pfizer Investigational Site, West Palm Beach, Florida 33407, United States

Pfizer Investigational Site, Bucheon-si, Gyunggi-do 420-767, Korea, Republic of

Pfizer Investigational Site, Aurora, Illinois 60504, United States

Pfizer Investigational Site, Pratt, Kansas 67124, United States

Pfizer Investigational Site, Shrevport, Louisiana 71106, United States

Pfizer Investigational Site, Milford, Massachusetts 01757, United States

Pfizer Investigational Site, Omaha, Nebraska 68114, United States

Pfizer Investigational Site, Westampton, New Jersey 08060, United States

Pfizer Investigational Site, Kingston, New York 12401, United States

Pfizer Investigational Site, New York, New York 10016, United States

Pfizer Investigational Site, Poughkeepsie, New York 12601, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Cincinnati, Ohio 45212, United States

Pfizer Investigational Site, Bethany, Oklahoma 73008, United States

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Sellersville, Pennsylvania 18960, United States

Pfizer Investigational Site, Houston, Texas 77024, United States

Pfizer Investigational Site, Salt Lake City, Utah 84107, United States

Pfizer Investigational Site, Salt Lake City, Utah 84124, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53209, United States

Additional Information

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

Starting date: January 2007
Last updated: February 24, 2009

Page last updated: August 23, 2015

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