Urinary Incontinence Clinical Trial
Official title:
Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder
The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10
mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence
episodes in female patients with overactive bladder. This is a multicenter, randomized,
double-blind, parallel-group study with two active treatments. Screened patients are
qualified for the study based on information obtained from seven consecutive 24-hour urinary
diaries completed during the Baseline Week, and other eligibility criteria. Qualifying
patients receive 12 weeks of treatment with DITROPAN® XL or DETROL® LA, with clinical visits
at the end of Weeks 2, 4, 8, and 12.
Safety evaluations during the study include the collection of adverse events, laboratory
tests including blood chemistry and urinalysis, physical examinations, vital signs (blood
pressure and heart rate) and post-void residual urine volume. Over-encapsulated DITROPAN®
XL, 10 mg tablets once-daily by mouth or over-encapsulated DETROL® LA, 4 mg capsules once
daily by mouth. The treatment phase of the study runs for 12 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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