Overactive Bladder Clinical Trial
Official title:
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
| Verified date | July 2016 |
| Source | Teva Pharmaceutical Industries |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1104 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Duramed Investigational Site | Oshawa | Ontario |
| Canada | Duramed Investigational Site | Thunder Bay | Ontario |
| Canada | Duramed Investigatinal Site | Vancouver | British Columbia |
| United States | Duramed Investigational Site | Albuquerque | New Mexico |
| United States | Duramed Investigational Site | Atlanta | Georgia |
| United States | Duramed Investigational Site | Augusta | Georgia |
| United States | Duramed Investigational Site | Aventura | Florida |
| United States | Duramed Investigational Site | Bethany | Oklahoma |
| United States | Duramed Investigational Site | Boise | Idaho |
| United States | Duramed Investigational Site | Boise | Idaho |
| United States | Duramed Investigational Site | Charlestown | South Carolina |
| United States | Duramed Investigational Site | Cleveland | Ohio |
| United States | Duramed Investigational Site | Coeur d'Alene | Idaho |
| United States | Duramed Investigational Site | Colorado Springs | Colorado |
| United States | Duramed Investigational Site | Columbia | South Carolina |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Danbury | Connecticut |
| United States | Duramed Investigation Site | Decatur | Georgia |
| United States | Duramed Investigational Site | Denver | Colorado |
| United States | Duramed Investigational Site | Encinitas | California |
| United States | Duramed Investigational Site | Eugene | Oregon |
| United States | Duramed Investigational Site | Fort Wayne | Indiana |
| United States | Duramed Investigational Site | Gainesville | Florida |
| United States | Duramed Investigational Site | Greensville | South Carolina |
| United States | Duramed Investigational Site | Hilton Head Island | South Carolina |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Huntsville | Alabama |
| United States | Duramed Investigational Site | Jackson | Tennessee |
| United States | Duramed Investigational Site | Jacksonville | Florida |
| United States | Duramed Investigational Site | Jeffersonville | Indiana |
| United States | Duramed Investigational Site | Lafayette | Louisiana |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Lawrenceville | New Jersey |
| United States | Duramed Investigational Site | Lebanon | New Hampshire |
| United States | Duramed Investigational Site | Little Rock | Arkansas |
| United States | Duramed Investigational Site | Los Angeles | California |
| United States | Duramed Investigational Site | Louisville | Kentucky |
| United States | Duramed Investigational Site | Marrero | Louisiana |
| United States | Duramed Investigational Site | Mayfield Heights | Ohio |
| United States | Duramed Investigational Site | Medford | Oregon |
| United States | Duramed Investigational Site | Meridian | Idaho |
| United States | Duramed Investigational Site | Miami | Florida |
| United States | Duramed Investigational Site | Milford | Connecticut |
| United States | Duramed Investigational Site | Mobile | Alabama |
| United States | Duramed Investigational Site | Montgomery | Alabama |
| United States | Duramed Investigational Site | Moorestown | New Jersey |
| United States | Duramed Investigational Site | N. Las Vegas | Nevada |
| United States | Duramed Investigational Site | New Bern | North Carolina |
| United States | Duramed Investigational Site | New Brunswick | New Jersey |
| United States | Duramed Investigational Site | New London | Connecticut |
| United States | Duramed Investigational Site | New Port Richey | Florida |
| United States | Duramed Investigational Site | Newton | Kansas |
| United States | Duramed Investigational Site | Norfolk | Virginia |
| United States | Duramed Investigational Site | Oklahoma City | Oklahoma |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Pittsburgh | Pennsylvania |
| United States | Duramed Investigational Site | Port Jefferson | New York |
| United States | Duramed Investigational Site | Pottstown | Pennsylvania |
| United States | Duramed Investigational Site | Salt Lake City | Utah |
| United States | Duramed Investigational Site | San Antonio | Texas |
| United States | Duramed Investigational Site | San Antonio | Texas |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | Savannah | Georgia |
| United States | Duramed Investigational Site | Seattle | Washington |
| United States | Duramed Investigational Site | Shreveport | Louisiana |
| United States | Duramed Investigational Site | South Bend | Indiana |
| United States | Duramed Investigational Site | Tacoma | Washington |
| United States | Duramed Investigational Site | Tampa | Florida |
| United States | Duramed Investigational Site | Tucson | Arizona |
| United States | Duramed Investigational Site | Tucson | Arizona |
| United States | Duramed Investigational Site | Waco | Texas |
| United States | Duramed Investigational Site | Watertown | Massachusetts |
| United States | Duramed Investigational Site | West Palm Beach | Florida |
| United States | Duramed Investigational Site | West Palm Beach | Florida |
| United States | Duramed Investigational Site | Wichita | Kansas |
| United States | Duramed Investigational Site | Williston | Vermont |
| United States | Duramed Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duramed Research |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in total weekly number of incontinence (urge and stress)episodes | Baseline to end-of-treamtent (Week 12/Early withdrawal) | No | |
| Secondary | Change in average daily urinary frequency and average void volume | Baseline to end-of-treamtent (Week 12/Early withdrawal) | No | |
| Secondary | Proportion of subjects with no incontinence episodes recorded in the final 3-day diary | Final 3-day diary | No | |
| Secondary | 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) | No | |
| Secondary | Adverse events (AEs) reported by subjects or identified by the investigator | Basline to end-of-treatment (Week 12/Early Withdrawal) | Yes |
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