A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
NCT00645281
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder. | |||
Official Title ICMJE | 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. | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Bladder, Overactive | |||
Intervention ICMJE | Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks | |||
Study Arms ICMJE | Experimental: tolterodine ER group
Intervention: Drug: tolterodine extended release | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 896 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00645281 | |||
Other Study ID Numbers ICMJE | A6121001 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |