Urinary Bladder, Overactive Clinical Trial
Official title:
Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.
| NCT number | NCT00645281 |
| Other study ID # | A6121001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | March 2004 |
| Est. completion date | January 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 896 |
| Est. completion date | January 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Bala-Cynwyd | Pennsylvania |
| United States | Pfizer Investigational Site | Barnesville | Georgia |
| United States | Pfizer Investigational Site | Beaufort | North Carolina |
| United States | Pfizer Investigational Site | Bensalem | Pennsylvania |
| United States | Pfizer Investigational Site | Bentonville | Arkansas |
| United States | Pfizer Investigational Site | Binghamton | New York |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Blackwood | New Jersey |
| United States | Pfizer Investigational Site | Blue Ridge | Georgia |
| United States | Pfizer Investigational Site | Bryan | Texas |
| United States | Pfizer Investigational Site | Buena Park | California |
| United States | Pfizer Investigational Site | Central Point | Oregon |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chipley | Florida |
| United States | Pfizer Investigational Site | Colleyville | Texas |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Connellsville | Pennsylvania |
| United States | Pfizer Investigational Site | Cordova | Tennessee |
| United States | Pfizer Investigational Site | Davie | Florida |
| United States | Pfizer Investigational Site | Decatur | Georgia |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | Endicott | New York |
| United States | Pfizer Investigational Site | Endwell | New York |
| United States | Pfizer Investigational Site | Foothill Ranch | California |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Friendswood | Texas |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Hallandale Beach | Florida |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntingdon | Tennessee |
| United States | Pfizer Investigational Site | Huntsville | Alabama |
| United States | Pfizer Investigational Site | Jackson | Michigan |
| United States | Pfizer Investigational Site | Jonesboro | Arkansas |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Kingston | New York |
| United States | Pfizer Investigational Site | Lakewood | Colorado |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Laurel | Maryland |
| United States | Pfizer Investigational Site | Lexington | Tennessee |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Marrero | Louisiana |
| United States | Pfizer Investigational Site | Medford | Oregon |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami Beach | Florida |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Montgomery | Alabama |
| United States | Pfizer Investigational Site | Morehead City | North Carolina |
| United States | Pfizer Investigational Site | Mount Laurel | New Jersey |
| United States | Pfizer Investigational Site | Murdock | Florida |
| United States | Pfizer Investigational Site | Naperville | Illinois |
| United States | Pfizer Investigational Site | New Berlin | Wisconsin |
| United States | Pfizer Investigational Site | Newton | Kansas |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Oregon | Wisconsin |
| United States | Pfizer Investigational Site | Orland Park | Illinois |
| United States | Pfizer Investigational Site | Oxon Hill | Maryland |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Portage | Michigan |
| United States | Pfizer Investigational Site | Saint Cloud | Florida |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Savannah | Tennessee |
| United States | Pfizer Investigational Site | Sellersville | Pennsylvania |
| United States | Pfizer Investigational Site | Selmer | Tennessee |
| United States | Pfizer Investigational Site | Shawnee Mission | Kansas |
| United States | Pfizer Investigational Site | Simpsonville | South Carolina |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Stoneboro | Pennsylvania |
| United States | Pfizer Investigational Site | Sun Lakes | Arizona |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| United States | Pfizer Investigational Site | Wauwatosa | Wisconsin |
| United States | Pfizer Investigational Site | Waynesboro | Tennessee |
| United States | Pfizer Investigational Site | West Covina | California |
| United States | Pfizer Investigational Site | West Jordan | Utah |
| United States | Pfizer Investigational Site | West Valley City | Utah |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry | 12 weeks | ||
| Secondary | OAB Bother Rating Scale at baseline | baseline | ||
| Secondary | Change from baseline to Week 4 and 12 in micturition bladder diary variables | 12 weeks | ||
| Secondary | Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition | 12 weeks | ||
| Secondary | Change from baseline to Week 4 and 12 in AUA Symptom Index | 12 weeks | ||
| Secondary | Change from baseline to Week 4 and 12 in OAB questionnaire | 12 weeks | ||
| Secondary | Clinical Global Impression-Improvement at Week 12 | 12 weeks | ||
| Secondary | Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 | 12 weeks | ||
| Secondary | To asses the safety of tolterodine in patients with OAB | 12 weeks |
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