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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine ER in Patients With Overactive Bladder.
This study has been completed.
First Received: January 28, 2008   Last Updated: November 23, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00611026
  Purpose

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


Condition Intervention Phase
Overactive Bladder
Drug: Tolterodine ER
Drug: Placebo
Drug: Fesoterodine
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To compare the efficacy of fesoterodine 4 mg QD with that of placebo in subjects with overactive bladder [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • To summarize safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2160
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Tolterodine ER
The tolterodine treatment will be 4 mg QD for 12 weeks.
2: Placebo Comparator Drug: Placebo
Placebo treatment will be QD for 12 weeks.
3: Experimental Drug: Fesoterodine
The fesoterodine treatment will start with 4 mg QD for 1 week followed by a forced dose-escalation to 8mg QD for 11 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
  • Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

  • Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
  • Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
  • Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611026

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Locations
United States, Alabama
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Montgomery, Alabama, United States, 36117
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Mobile, Alabama, United States, 36608
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Enterprise, Alabama, United States, 36330
United States, Arizona
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Tucson, Arizona, United States, 85741
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Peoria, Arizona, United States, 85381
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Chandler, Arizona, United States, 85225
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Vista, California, United States, 92083
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Torrance, California, United States, 90505
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Anaheim, California, United States, 92801
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San Diego, California, United States, 92103
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Westlake Village, California, United States, 91361
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Fresno, California, United States, 93720
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Upland, California, United States, 91786
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Clovis, California, United States, 93611
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Fresno, California, United States, 93710
United States, Colorado
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Englewood, Colorado, United States, 80112
United States, Connecticut
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New London, Connecticut, United States, 06320
United States, Florida
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Loxahatchee, Florida, United States, 33470
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West Palm Beach, Florida, United States, 33409
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Longwood, Florida, United States, 32779
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Lake Worth, Florida, United States, 33461
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32216
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Tallahassee, Florida, United States, 32308
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Pembroke Pines, Florida, United States, 33024
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Miami, Florida, United States, 33143
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Leesburg, Florida, United States, 34748
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Bonita Spring, Florida, United States, 34134
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Naples, Florida, United States, 34102
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Stuart, Florida, United States, 34996
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33186
United States, Georgia
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30308
United States, Idaho
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Meridian, Idaho, United States, 83642
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Chicago, Illinois, United States, 60654
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Peoria, Illinois, United States, 61614
United States, Indiana
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Avon, Indiana, United States, 46123
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Evansville, Indiana, United States, 47714
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Noblesville, Indiana, United States, 46158
United States, Kansas
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Overland Park, Kansas, United States, 66210
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Overland Park, Kansas, United States, 66215
United States, Kentucky
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Louisville, Kentucky, United States, 40207
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Louisville, Kentucky, United States, 40291
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Lexington, Kentucky, United States, 40504
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Lexington, Kentucky, United States, 40509
United States, Louisiana
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Metairie, Louisiana, United States, 70002
United States, Maryland
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Baltimore, Maryland, United States, 21211
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Bel Air, Maryland, United States, 21014
United States, Massachusetts
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North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
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Ann Arbor, Michigan, United States, 48103
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Royal Oak, Michigan, United States, 48073
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Troy, Michigan, United States, 48098
United States, Minnesota
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Edina, Minnesota, United States, 55435
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Sartell, Minnesota, United States, 56377
United States, Mississippi
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Picayune, Mississippi, United States, 39466
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Olive Branch, Mississippi, United States, 38654
United States, Missouri
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St. Louis, Missouri, United States, 63117
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Kansas City, Missouri, United States, 64114
United States, Nebraska
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Lincoln, Nebraska, United States, 68506
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68134
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Las Vegas, Nevada, United States, 89148
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Hamilton, New Jersey, United States, 08690
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Williamsville, New York, United States, 14221
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Winston-Salem, North Carolina, United States, 27103
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Cary, North Carolina, United States, 27518
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Raleigh, North Carolina, United States, 27612
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Raleigh, North Carolina, United States, 27609
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Cincinnati, Ohio, United States, 45212
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Cincinnati, Ohio, United States, 45249
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Bensalem, Pennsylvania, United States, 19020
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Pittsburgh, Pennsylvania, United States, 15243
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Uniontown, Pennsylvania, United States, 15401
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Philadelphia, Pennsylvania, United States, 19114
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Pawtucket, Rhode Island, United States, 02860
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Cumberland, Rhode Island, United States, 02864
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Summerville, South Carolina, United States, 29485
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Greer, South Carolina, United States, 29651
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Anderson, South Carolina, United States, 29621
United States, Tennessee
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Johnson City, Tennessee, United States, 37601
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New Tazewell, Tennessee, United States, 37825
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Nashville, Tennessee, United States, 37203
United States, Texas
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Plano, Texas, United States, 75024
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Plano, Texas, United States, 75093
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San Antonio, Texas, United States, 78229
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Beaumont, Texas, United States, 77701
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Beaumont, Texas, United States, 77706
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Sugar Land, Texas, United States, 77479
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Bryan, Texas, United States, 77802
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West Jordan, Utah, United States, 84088
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Midvale, Utah, United States, 84047
United States, Virginia
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Virginia Beach, Virginia, United States, 23455
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Charlottesville, Virginia, United States, 22911
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Richmond, Virginia, United States, 23294
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Arlington, Virginia, United States, 22205
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Weber City, Virginia, United States, 24290
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Virginia Beach, Virginia, United States, 23464
United States, Washington
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Seattle, Washington, United States, 98166
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Spokane, Washington, United States, 99207
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Seattle, Washington, United States, 98104
Brazil, BA
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Salvador, BA, Brazil, 40420-000
Brazil, GO
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Goiania, GO, Brazil, 74175-080
Brazil, PR
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Curitiba, PR, Brazil, 80030-220
Brazil, RJ
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Rio de Janeiro, RJ, Brazil, CEP 20551-030
Brazil, RS
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Porto Alegre, RS, Brazil, 90470-340
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Sao Paulo, SP, Brazil, 04025-001
Bulgaria
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Sofia, Bulgaria, 1606
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Veliko Tarnovo, Bulgaria, 5000
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Plovdiv, Bulgaria, 4003
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Pernik, Bulgaria, 2300
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Surrey, British Columbia, Canada, V3V 1N1
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Winnipeg, Manitoba, Canada, R3C 0N2
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Oshawa, Ontario, Canada, L1H 7K4
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Trois-Rivieres, Quebec, Canada, G9A 3V7
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Chicoutimi, Quebec, Canada, G7H 4A3
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H2X 1N8
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Montreal, Quebec, Canada, H2X 3J4
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 1N8
Colombia
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Bogota, Colombia
Colombia, Atlantico
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Costa Rica
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Alajuela, Costa Rica
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Cartago, Costa Rica
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San Jose, Costa Rica
Estonia
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Tallinn, Estonia, 10611
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Tartu, Estonia, 51014
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Tallinn, Estonia, 10138
Germany
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Muenchen, Germany, 81925
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Muenchen, Germany, 81241
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Krumbach, Germany, 86381
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Marburg, Germany, 35039
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Muelheim A.d. Ruhr, Germany, 45468
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Leipzig, Germany, 04103
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Hamburg, Germany, 20253
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Berlin, Germany, 10629
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Gruenstadt, Germany, 67269
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Berlin, Germany, 10787
Greece
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Larisa, Greece, 41110
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Athens, Maroussi, Greece, 14126
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Alexandroupolis, Greece, 68100
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Thessaloniki, Greece, 546 35
Greece, Crete
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Heraklion/Voutes, Crete, Greece, 71001
Hungary
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Szentes, Hungary, 6600
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Nyiregyhaza, Hungary, 4400
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Salgotarjan, Hungary, 3100
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Gyor, Hungary, 9023
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Debrecen, Hungary, 4043
India
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New Delhi, India, 110001
India, Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500 001
India, Gujarat
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Ahmedabad, Gujarat, India, 380 009
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Nadiad, Gujarat, India, 387 001
India, Karnataka
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Bengaluru, Karnataka, India, 560 010
India, Maharashtra
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Pune, Maharashtra, India, 411 053
Ireland
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Dublin, Ireland, 9
Ireland, Dublin
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Beaumont, Dublin, Ireland, 9
Korea, Republic of
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Suwon, Korea, Republic of, 443-721
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Incheon, Korea, Republic of, 405-760
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Seoul, Korea, Republic of, 134-791
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Daegu, Korea, Republic of, 700-721
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Busan, Korea, Republic of, 602-715
Korea, Republic of, Chonbuk
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Chonju, Chonbuk, Korea, Republic of, 561-712
Latvia
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Riga, Latvia, LV 1002
Lithuania
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Vilnius, Lithuania, 01118
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Klaipeda, Lithuania, 94231
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Kaunas, Lithuania, 50425
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Kaunas, Lithuania, 49476
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Vilnius, Lithuania, 10207
Malaysia
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Kuala Lumpur, Malaysia, 50586
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Kuala Lumpur, Malaysia, 59100
Poland
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Slupsk, Poland, 76-200
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Bialystok, Poland, 15-276
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Lublin, Poland, 20-954
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Bydgoszcz, Poland, 85-094
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Krakow, Poland, 30-017
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Poznan, Poland, 61-251
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Gdynia, Poland, 81-366
Romania
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Arad, Romania, 310175
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Bucuresti, Romania, 041345
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Sibiu, Romania, 550245
Romania, Sector 5,
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Bucuresti, Sector 5,, Romania, 050653
Russian Federation
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Moscow, Russian Federation, 119991
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Moscow, Russian Federation, 109388
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Saint-Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 190013
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Moscow, Russian Federation, 105425
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Moscow, Russian Federation, 115516
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Rostov-on-Don, Russian Federation, 344022
Pfizer Investigational Site
Moscow, Russian Federation, 117997
Pfizer Investigational Site
Moscow, Russian Federation, 101000
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Saint-Petersburg, Russian Federation, 196247
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Saint-Petersburg, Russian Federation, 199106
Singapore
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Singapore, Singapore, 229899
Slovakia
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Presov, Slovakia, 080 01
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Nitra, Slovakia, 949 01
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Trencin, Slovakia, 911 01
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Povazska Bystrica, Slovakia, 017 01
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Zvolen, Slovakia, 960 01
South Africa
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Pretoria, South Africa, 0083
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Roodepoort, South Africa, 1715
South Africa, Cape Town
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Claremont, Cape Town, South Africa, 8001
South Africa, Free State
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Bloemfontein, Free State, South Africa, 9301
South Africa, Gauteng
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Vosloorus, Gauteng, South Africa, 1475
South Africa, Kwa Zulu Natal
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Durban, Kwa Zulu Natal, South Africa
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Pietermaritzburg, Kwa Zulu Natal, South Africa, 3201
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Durban, Kwa Zulu Natal, South Africa, 4001
Spain
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Valencia, Spain, 46009
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Madrid, Spain, 28040
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Las Palmas de Gran Canaria, Spain, 35010
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Valencia, Spain, 46017
Spain, CANTABRIA
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Santander, CANTABRIA, Spain, 39008
Spain, Santa Cruz De Tenerife
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La Laguna, Santa Cruz De Tenerife, Spain, 38320
Sweden
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Stockholm, Sweden
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Karlskoga, Sweden, 691 81
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Skovde, Sweden, 541 85
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Orebro, Sweden, 701 46
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Norrkoping, Sweden, 601 82
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Malmo, Sweden, 211 52
Ukraine
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Dnipropetrovsk, Ukraine, 49005
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Zaporizhzhia, Ukraine, 69000
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Uzhorod, Ukraine, 88000
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Kyiv, Ukraine, 04053
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Chernivtsi, Ukraine, 58002
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A0221046
Study First Received: January 28, 2008
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00611026     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Treatment of overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tolterodine

ClinicalTrials.gov processed this record on November 27, 2009