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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

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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tolterodine ER group

Group Type EXPERIMENTAL

tolterodine extended release

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* self-reported symptoms of OAB for ≥ 3 months prior to screening
* 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 condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Birmingham, Alabama, United States

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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

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Wauwatosa, Wisconsin, United States

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Countries

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United States

Related Links

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Other Identifiers

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A6121001

Identifier Type: -

Identifier Source: org_study_id

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