Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

NCT00611026 | Completed Phase 3 Results

• 1 other identifier: A0221046
• Study Type: interventional
• Target: 2,417
• Locations: 23 countries
• Sites: 222

Brief Summary

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

Conditions

Overactive Bladder

Keywords

Treatment of 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

  UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  Baseline, Week 12

Secondary Outcomes (18)

• Change From Baseline in Mean Voided Volume Per Micturition

  Baseline, Week 1, Week 4, Week 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours

  Baseline, Week 1, Week 4, Week 12

• Percent Change From Baseline of Micturitions Per 24 Hours

  Baseline, Week 1, Week 4, Week 12

• Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours

  Baseline, Week 1, Week 4, Week 12

• Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours

  Baseline, Week 1, Week 4, Week 12

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: Tolterodine ER

2

PLACEBO COMPARATOR

Drug: Placebo

3

EXPERIMENTAL

Drug: Fesoterodine

Interventions

Tolterodine ER DRUG

The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.

1

Placebo DRUG

Placebo treatment will be once daily(QD) for 12 weeks.

2

Fesoterodine DRUG

The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (227)

Pfizer Investigational Site

Enterprise, Alabama, 36330, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36117, United States

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Chandler, Arizona, 85225, United States

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Peoria, Arizona, 85381, United States

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Tucson, Arizona, 85741, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92801, United States

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Clovis, California, 93611, United States

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Fresno, California, 93710, United States

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Fresno, California, 93720, United States

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San Diego, California, 92103, United States

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Torrance, California, 90505, United States

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Upland, California, 91786, United States

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Vista, California, 92083, United States

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Westlake Village, California, 91361, United States

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Englewood, Colorado, 80112, United States

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New London, Connecticut, 06320, United States

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Bonita Spring, Florida, 34134, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Lake Worth, Florida, 33461, United States

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Leesburg, Florida, 34748, United States

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Longwood, Florida, 32779, United States

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Loxahatchee Groves, Florida, 33470, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33186, United States

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Naples, Florida, 34102, United States

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Pembroke Pines, Florida, 33024, United States

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Stuart, Florida, 34996, United States

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Tallahassee, Florida, 32308, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30342, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60654, United States

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Peoria, Illinois, 61614, United States

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Avon, Indiana, 46123, United States

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Evansville, Indiana, 47714, United States

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Noblesville, Indiana, 46158, United States

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Overland Park, Kansas, 66210, United States

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Overland Park, Kansas, 66215, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40207, United States

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Louisville, Kentucky, 40291, United States

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Metairie, Louisiana, 70002, United States

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Baltimore, Maryland, 21211, United States

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Bel Air, Maryland, 21014, United States

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North Dartmouth, Massachusetts, 02747, United States

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Ann Arbor, Michigan, 48103, United States

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Royal Oak, Michigan, 48073, United States

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Troy, Michigan, 48098, United States

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Edina, Minnesota, 55435, United States

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Sartell, Minnesota, 56377, United States

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Olive Branch, Mississippi, 38654, United States

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Picayune, Mississippi, 39466, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63117, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89148, United States

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Hamilton, New Jersey, 08690, United States

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Williamsville, New York, 14221, United States

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Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27609, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45249, United States

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Bensalem, Pennsylvania, 19020, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Uniontown, Pennsylvania, 15401, United States

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Cumberland, Rhode Island, 02864, United States

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Pawtucket, Rhode Island, 02860, United States

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Anderson, South Carolina, 29621, United States

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Greer, South Carolina, 29651, United States

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Summerville, South Carolina, 29485, United States

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Johnson City, Tennessee, 37601, United States

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Nashville, Tennessee, 37203, United States

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New Tazewell, Tennessee, 37825, United States

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Beaumont, Texas, 77701, United States

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Beaumont, Texas, 77706, United States

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Bryan, Texas, 77802, United States

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Plano, Texas, 75024, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Midvale, Utah, 84047, United States

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West Jordan, Utah, 84088, United States

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Arlington, Virginia, 22205, United States

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Charlottesville, Virginia, 22911, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23455, United States

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Virginia Beach, Virginia, 23464, United States

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Weber City, Virginia, 24290, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98166, United States

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Spokane, Washington, 99207, United States

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Salvador, Estado de Bahia, 40420-000, Brazil

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Goiânia, Goiás, 74175-080, Brazil

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Curitiba, Paraná, 80030-220, Brazil

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Rio de Janeiro, Rio de Janeiro, CEP 20551-030, Brazil

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Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

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São Paulo, São Paulo, 04025-001, Brazil

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Pernik, 2300, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sofia, 1606, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Surrey, British Columbia, V3V 1N1, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Oshawa, Ontario, L1H 7K4, Canada

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Chicoutimi, Quebec, G7H 4A3, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2X 1N8, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Trois-Rivières, Quebec, G9A 3V7, Canada

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Saskatoon, Saskatchewan, S7K 1N8, Canada

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Barranquilla, Atlántico, 0, Colombia

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Bogotá, Colombia, Colombia

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Alajuela, Alajuela Province, Costa Rica

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Cartago, Cartago Province, Costa Rica

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San José, Provincia de San José, Costa Rica

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Tallinn, 10138, Estonia

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Tallinn, 10611, Estonia

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Tartu, 51014, Estonia

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Berlin, 10629, Germany

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Berlin, 10787, Germany

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Grünstadt, 67269, Germany

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Hamburg, 20253, Germany

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Krumbach, 86381, Germany

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Leipzig, 04103, Germany

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Marburg, 35039, Germany

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Muelheim A.d. Ruhr, 45468, Germany

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München, 81241, Germany

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München, 81925, Germany

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Heraklion/Voutes, Crete, 71001, Greece

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Alexandroupoli, 68100, Greece

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Athens, Maroussi, 14126, Greece

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Larissa, 41110, Greece

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Thessaloniki, 546 35, Greece

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Debrecen, 4043, Hungary

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Győr, 9023, Hungary

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Nyíregyháza, 4400, Hungary

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Salgótarján, 3100, Hungary

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Szentes, 6600, Hungary

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Hyderabad, Andhra Pradesh, 500 001, India

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Ahmedabad, Gujarat, 380 009, India

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Nadiād, Gujarat, 387 001, India

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Bengaluru, Karnataka, 560 010, India

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Pune, Maharashtra, 411 053, India

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New Delhi, 110001, India

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Beaumont, Dublin, 9, Ireland

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Dublin, 9, Ireland

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Riga, LV 1002, Latvia

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Kaunas, 49476, Lithuania

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Kaunas, 50425, Lithuania

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Klaipėda, 94231, Lithuania

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Vilnius, 01118, Lithuania

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Vilnius, 10207, Lithuania

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Bialystok, 15-276, Poland

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Bydgoszcz, 85-094, Poland

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Gdynia, 81-366, Poland

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Krakow, 30-017, Poland

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Lublin, 20-954, Poland

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Poznan, 61-251, Poland

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Słupsk, 76-200, Poland

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Bucharest, București, 041345, Romania

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Bucharest, Sector 5,, 050653, Romania

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Sibiu, Sibiu County, 550245, Romania

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Arad, 310175, Romania

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Moscow, 101000, Russia

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Moscow, 105425, Russia

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Moscow, 109388, Russia

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Moscow, 115516, Russia

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Moscow, 117997, Russia

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Moscow, 119991, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 190013, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 199106, Russia

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Singapore, Singapore, 229899, Singapore

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Nitra, 949 01, Slovakia

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Považská Bystrica, 017 01, Slovakia

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Prešov, 080 01, Slovakia

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Trenčín, 911 01, Slovakia

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Zvolen, 960 01, Slovakia

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Claremont, Cape Town, 8001, South Africa

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Bloemfontein, Free State, 9301, South Africa

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Vosloorus, Gauteng, 1475, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Durban, KwaZulu-Natal, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

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Pretoria, 0083, South Africa

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Roodepoort, 1715, South Africa

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Jeonju, Jeollabuk-do, 561-712, South Korea

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Busan, 602-715, South Korea

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Daegu, 700-721, South Korea

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Incheon, 405-760, South Korea

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Seoul, 134-791, South Korea

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Suwon, 443-721, South Korea

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Santander, Cantabria, 39008, Spain

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Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35010, Spain

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Madrid, Madrid, 28040, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

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Valencia, Valencia, 46009, Spain

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Valencia, Valencia, 46017, Spain

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Karlskoga, 691 81, Sweden

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Malmo, 211 52, Sweden

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Norrköping, 601 82, Sweden

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Örebro, 701 46, Sweden

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Skövde, 541 85, Sweden

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Stockholm, Sweden

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Chernivtsi, 58002, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Kyiv, 04053, Ukraine

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Uzhhorod, 88000, Ukraine

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Zaporizhzhia, 69000, Ukraine

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Related Publications (2)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

• Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

  PMID: 35881009 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate; 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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 2, 2011
• Results First Posted: January 12, 2011

Record last verified: 2011-01

Locations

CO (3); SL (5); BR (6); RU (11); CA (10); LI (5); MY (2); RO (4); ZA (8); UA (5); PL (7); IN (6); ES (6); BU (6); SG (1); GR (5); LA (1); KR (6); US (102); SE (6); HU (5); DE (10); IE (2)