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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.

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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

Sponsor

Duramed Research

23 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.