A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Overview
- Phase
- Phase 2
- Intervention
- DR-3001a
- Conditions
- Urinary Incontinence
- Sponsor
- Duramed Research
- Enrollment
- 800
- Locations
- 3
- Primary Endpoint
- Change in the total weekly number of incontinence episodes
- Status
- Completed
- Last Updated
- 13 years ago
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
Investigators
Eligibility Criteria
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
2
Intervention: DR-3001b
3
Intervention: Placebo
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)