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NCT00196404 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

A Phase 2 study of Urinary Incontinence, sponsored by Duramed Research.

Completed
Registry status
Phase 2
Development phase
800
Enrollment target
20
Study locations

NCT00196404 is a Phase 2 study of Urinary Incontinence that has completed, run by Duramed Research. The registered enrollment target is 800 participants, above the 245-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (227% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT00196404, a Phase 2 study of Urinary Incontinence, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 2
Development phase
800 participants
Enrollment target
20
Study locations

Study Summary

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG DR-3001a
  • DRUG DR-3001b

Study Locations (20)

Alabama

  • Duramed Investigational Site - Birmingham
  • Duramed Investigational Site - Huntsville
  • Duramed Investigational Site - Mobile

Colorado

  • Duramed Investigational Site - Aurora
  • Duramed Research Site - Colorado Springs
  • Duramed Investigational Site - Denver

Indiana

  • Duramed Investigational Site - Boise
  • Duramed Investigational Site - Evansville
  • Duramed Investigational Site - Fort Wayne

Arizona

  • Duramed Research Site - Phoenix
  • Duramed Research Site - Tucson

California

  • Duramed Investigational Site - San Diego
  • Duremed Research Site - San Diego

Florida

  • Duramed Investigational Site - Aventura
  • Duramed Research Site - Gainesville

Georgia

  • Duramed Investigational Site - Decatur
  • Duramed Research Site - Sandy Springs

Arkansas

  • Duramed Investigational Site - Little Rock

Trial Details

FieldValue
Enrollment Target 800 participants
Start Date 2004-10
Est. Completion 2006-12
Phase Phase 2

Sponsor

Duramed Research

23 total trials

What the Registry Record Tells You About NCT00196404

The ClinicalTrials.gov registry entry for NCT00196404 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 245-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (227% higher). The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urinary Incontinence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00196404 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Alabama, Colorado, Indiana.

Frequently Asked Questions

What is clinical trial NCT00196404 about?

NCT00196404 is a clinical study titled "Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder". This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

What is the current status of trial NCT00196404?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2004-10. Estimated completion is 2006-12.

What conditions does trial NCT00196404 study?

This clinical trial studies the following conditions: Urinary Incontinence.

What interventions are being tested in trial NCT00196404?

The interventions under investigation include: Placebo (OTHER), DR-3001a (DRUG), DR-3001b (DRUG).

Who is sponsoring clinical trial NCT00196404?

This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00196404 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.