A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder - NCT00685113-30034 (Clinical Trial 222924)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy222924.aspx
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| City: |
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Decatur |
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State:
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GA |
| Zip Code: |
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30034 |
| Conditions: |
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Overactive Bladder |
| Purpose: |
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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.
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| Study summary: |
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| 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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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October 9, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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