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NCT00685113 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,104
- Enrollment target
NCT00685113 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 1,104 participants.
The verdict
NCT00685113, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,104 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG DR-3001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,104 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00685113
The ClinicalTrials.gov registry entry for NCT00685113 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00685113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00685113 about?
NCT00685113 is a clinical study titled "A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder". 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 hav...
What is the current status of trial NCT00685113?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,104 participants. The study started on 2008-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00685113?
The interventions under investigation include: Placebo (DRUG), DR-3001 (DRUG).
Who is sponsoring clinical trial NCT00685113?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
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