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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: Completed Phase 3 study, sponsored by Duramed Research.

NCT00685113 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 1,104 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1,104 participants
Start Date 2008-05
Est. Completion 2010-03
Phase Phase 3
Duramed Research

23 total trials

What the finished NCT00685113 record still lists

NCT00685113 is an interventional study that assigns participants to a tested intervention. Its 1,104 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00685113 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00685113's enrollment target sits among peer trials

1,104 252nd of 2000 higher than 1,749 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00685113, the US trial registry maintained by the National Library of Medicine. NCT00685113 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.