A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
NCT ID: NCT00645281
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
896 participants
INTERVENTIONAL
2004-03-31
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tolterodine ER group
tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Interventions
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tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
* urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
* patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale
Exclusion Criteria
* any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
* stress incontinence, functional, or overflow incontinence as determined by the investigator
* symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI \>3 times in the 12 months prior to participation in this clinical trial
* clinically significant urinary tract obstruction
* history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
* clinically significant interstitial cystitis or significant bladder pain syndrome
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
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
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Sun Lakes, Arizona, United States
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Bentonville, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Buena Park, California, United States
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Foothill Ranch, California, United States
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Fresno, California, United States
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West Covina, California, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Chipley, Florida, United States
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Davie, Florida, United States
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Hallandale, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Murdock, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Saint Cloud, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Barnesville, Georgia, United States
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Blue Ridge, Georgia, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Naperville, Illinois, United States
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Orland Park, Illinois, United States
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Newton, Kansas, United States
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Shawnee Mission, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Marrero, Louisiana, United States
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Laurel, Maryland, United States
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Oxon Hill, Maryland, United States
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Jackson, Michigan, United States
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Portage, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Blackwood, New Jersey, United States
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Mount Laurel, New Jersey, United States
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Binghamton, New York, United States
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Endicott, New York, United States
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Endwell, New York, United States
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Kingston, New York, United States
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Beaufort, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Central Point, Oregon, United States
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Medford, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Connellsville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Stoneboro, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Greer, South Carolina, United States
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Simpsonville, South Carolina, United States
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Cordova, Tennessee, United States
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Huntingdon, Tennessee, United States
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Lexington, Tennessee, United States
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Savannah, Tennessee, United States
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Selmer, Tennessee, United States
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Waynesboro, Tennessee, United States
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Austin, Texas, United States
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Bryan, Texas, United States
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Colleyville, Texas, United States
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Friendswood, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Plano, Texas, United States
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San Antonio, 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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West Jordan, Utah, United States
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West Valley City, Utah, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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New Berlin, Wisconsin, United States
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Oregon, Wisconsin, United States
Pfizer Investigational Site
Wauwatosa, Wisconsin, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6121001
Identifier Type: -
Identifier Source: org_study_id
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