This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency
This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Change in the total weekly number of incontinence episodes
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Average daily urinary frequency
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
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Duramed Investigational Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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San Diego, California, United States
Duremed Research Site
San Diego, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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