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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-3001a | Drug | 4mg daily vaginally |
| |
| DR-3001b |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the total weekly number of incontinence episodes | Baseline to Treatment Week 12/Premature Discontinuation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Duramed Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Duramed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37160401 | Derived | Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
| Label | URL |
|---|---|
| MedLine Plus - Urinary Incontinence | View source |
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| Drug |
6 mg vaginally daily |
|
| Placebo | Other | Administered vaginally to match experimental arms |
|
| Average void volume | Baseline to Treatment Week 12/Premature Discontinuation |
| Average severity of urgency | Baseline to Treatment Week 12/Premature Discontinuation |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Duramed Investigational Site | Mobile | Alabama | 36608 | United States |
| Duramed Research Site | Phoenix | Arizona | 85015 | United States |
| Duramed Research Site | Tucson | Arizona | 85712 | United States |
| Duramed Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duremed Research Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | Aurora | Colorado | 80012 | United States |
| Duramed Research Site | Colorado Springs | Colorado | 80909 | United States |
| Duramed Investigational Site | Denver | Colorado | 80220 | United States |
| Duramed Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Duramed Investigational Site | Aventura | Florida | 33180 | United States |
| Duramed Research Site | Gainesville | Florida | 32607 | United States |
| Duramed Investigational Site | Decatur | Georgia | 30034 | United States |
| Duramed Research Site | Sandy Springs | Georgia | 30328 | United States |
| Duramed Investigational Site | Boise | Idaho | 83712 | United States |
| Duramed Investigational Site | Boise | Indiana | 83705 | United States |
| Duramed Investigational Site | Evansville | Indiana | 47714 | United States |
| Duramed Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| Duramed Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Duramed Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Duramed Investigational Site | Meridian | Indiana | 83642 | United States |
| Duramed Investigational Site | Shreveport | Louisiana | 71106 | United States |
| Duramed Investigational Site | Jackson | Mississippi | 39202 | United States |
| Duramed Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Duramed Investigational Site | Edison | New Jersey | 08837 | United States |
| Duramed Investigational Site | Livingston | New Jersey | 07039 | United States |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Duramed Investigational Site | Williamsville | New York | 14221 | United States |
| Duramed Investigational Site | Portland | Oregon | 97210 | United States |
| Duramed Investigational Site | Lancaster | Pennsylvania | 17604 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Providence | Rhode Island | 02904 | United States |
| Duramed Investigational Site | Charleston | South Carolina | 29425 | United States |
| Duramed Investigational Site | Jackson | Tennessee | 38305 | United States |
| Duramed Investigational Site | Memphis | Tennessee | 38120 | United States |
| Duramed Investigational Site | Nashville | Tennessee | 37232 | United States |
| Duramed Investigational Site | Dallas | Texas | 75234 | United States |
| Duramed Research Site | Houston | Texas | 77024 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| Duramed Research Site | Waco | Texas | 76712 | United States |
| Duramed Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Duramed Investigational Site | Seattle | Washington | 98105 | United States |
| Duramed Research Site | Tacoma | Washington | 98405 | United States |
| Duramed Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Duramed Investigational Site | Vancouver | British Columbia | V6T2B5 | Canada |
| Duramed Investigational Site | Toronto | Ontario | M4N3M5 | Canada |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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