Status:
COMPLETED
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
896 Patients enrolled
Trial Details
Trial ID
NCT00645281
Start Date
March 1 2004
End Date
January 1 2005
Last Update
January 27 2021
Active Locations (96)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35234
4
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801