A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

Study Overview
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Brief Summary
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This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: DR-3001
* Drug: DR-3001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months Able to distinguish between stress and urge incontinence During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries Others as dictated by FDA-approved protocol Exclusion Criteria: Stress incontinence, continuous incontinence or overflow urinary incontinence Chronic illness, neurological dysfunction or injury that could cause incontinence Pregnant, breastfeeding, or gave birth in the last 6 months Others as dictated by FDA-approved protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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-3001<br>* 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks<br>* Other names: Oxybutinyn Vaginal Ring;|
| Experimental: 2<br> | Drug: DR-3001<br>* 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks<br>* Other names: Oxybutinyn Vaginal Ring;|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo vaginal ring inserted vaginally and replaced every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total weekly number of incontinence (urge and stress)episodes |  | Baseline to end-of-treamtent (Week 12/Early withdrawal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average daily urinary frequency and average void volume |  | Baseline to end-of-treamtent (Week 12/Early withdrawal) | 
| Proportion of subjects with no incontinence episodes recorded in the final 3-day diary |  | Final 3-day diary | 
| 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question |  | Baseline to end-of-treatment (Week 12/Early Withdrawal) | 
| Adverse events (AEs) reported by subjects or identified by the investigator |  | Basline to end-of-treatment (Week 12/Early Withdrawal) |