Overactive Bladder Clinical Trial
Official title:
A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder
| NCT number | NCT00782769 |
| Other study ID # | DR-OXY-302 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | September 2008 |
| Est. completion date | July 2010 |
| Verified date | March 2023 |
| Source | Teva Branded Pharmaceutical Products R&D, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Completed the 12 weeks of treatment in the DR-OXY-301 study - Willing to limit medications for overactive bladder to investigational product only - Able to understand and complete all study procedures including the required diary |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duramed Investigational Site | Albuquerque | New Mexico |
| United States | Duramed Investigational Site | Augusta | Georgia |
| United States | Duramed Investigational Site | Boise | Idaho |
| United States | Duramed Investigational Site | Chicago | Illinois |
| United States | Duramed Investigational Site | Columbia | South Carolina |
| United States | Duramed Investigational Site | Eugene | Oregon |
| United States | Duramed Investigational Site | Hilton Head Island | South Carolina |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Jackson | Tennessee |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Louisville | Kentucky |
| United States | Duramed Investigational Site | Medford | Oregon |
| United States | Duramed Investigational Site | Miami | Florida |
| United States | Duramed Investigational Site | Moorestown | New Jersey |
| United States | Duramed Investigational Site | New Bern | North Carolina |
| 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 | 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 | Tacoma | Washington |
| United States | Duramed Investigational Site | Tampa | Florida |
| United States | Duramed Investigational Site | Waco | Texas |
| United States | Duramed Investigational Site | Watertown | Massachusetts |
| United States | Duramed Investigational Site | Wichita | Kansas |
| United States | Duramed Investigational Site | Williston | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| Duramed Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported | Duration of Study |
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