Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

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

Official Title
-----------------
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: DR-3001a
* Drug: DR-3001b
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-3001a<br>* 4mg daily vaginally<br>|
| Experimental: 2<br> | Drug: DR-3001b<br>* 6 mg vaginally daily<br>|
| Placebo Comparator: 3<br> | Other: Placebo<br>* Administered vaginally to match experimental arms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the total weekly number of incontinence episodes |  | Baseline to Treatment Week 12/Premature Discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily urinary frequency |  | Baseline to Treatment Week 12/Premature Discontinuation | 
| Proportion of patients with no incontinence episodes |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overactive bladder, urge incontinence, urinary incontinence