A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 800
- Locations
- 3
- Primary Endpoint
- Change in the total weekly number of incontinence episodes
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of overactive bladder and incontinence for at least 6 months
- •Using birth control or menopausal
- •Willing to discontinue current medication for overactive bladder
Exclusion Criteria
- •Pregnant or given birth in the last 6 months
- •Three or more urinary tract infections a year
- •Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
- •History of bladder cancer, ulcerative colitis or severe constipation
- •Any contraindication to vaginal delivery systems
Arms & Interventions
1
Intervention: DR-3001a (Drug)
2
Intervention: DR-3001b (Drug)
3
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in the total weekly number of incontinence episodes
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Secondary Outcomes
- Average daily urinary frequency(Baseline to Treatment Week 12/Premature Discontinuation)
- Average void volume(Baseline to Treatment Week 12/Premature Discontinuation)
- Average severity of urgency(Baseline to Treatment Week 12/Premature Discontinuation)
- Proportion of patients with no incontinence episodes(Baseline to Treatment Week 12/Premature Discontinuation)