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

August 17, 2012 updated by: Duramed Research

A Multicenter, Randomized, Double-blind 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T2B5
        • Duramed Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Duramed Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Duramed Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Duramed Investigational Site
      • Mobile, Alabama, United States, 36608
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Duramed Research Site
      • Tucson, Arizona, United States, 85712
        • Duramed Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Duramed Investigational Site
    • California
      • San Diego, California, United States, 92108
        • Duramed Investigational Site
      • San Diego, California, United States, 92108
        • Duremed Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Duramed Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Duramed Research Site
      • Denver, Colorado, United States, 80220
        • Duramed Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Duramed Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Duramed Investigational Site
      • Gainesville, Florida, United States, 32607
        • Duramed Research Site
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Duramed Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Duramed Research Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Duramed Investigational Site
    • Indiana
      • Boise, Indiana, United States, 83705
        • Duramed Investigational Site
      • Evansville, Indiana, United States, 47714
        • Duramed Investigational Site
      • Fort Wayne, Indiana, United States, 46825
        • Duramed Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Duramed Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Duramed Investigational Site
      • Meridian, Indiana, United States, 83642
        • Duramed Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Duramed Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Duramed Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Duramed Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Duramed Investigational Site
      • Livingston, New Jersey, United States, 07039
        • Duramed Investigational Site
      • Moorestown, New Jersey, United States, 08057
        • Duramed Investigational Site
    • New York
      • Williamsville, New York, United States, 14221
        • Duramed Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Duramed Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Duramed Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Duramed Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Duramed Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Duramed Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Duramed Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Duramed Investigational Site
    • Texas
      • Dallas, Texas, United States, 75234
        • Duramed Investigational Site
      • Houston, Texas, United States, 77024
        • Duramed Research Site
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site
      • Waco, Texas, United States, 76712
        • Duramed Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Duramed Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of overactive bladder and incontinence for at least 6 months
  • Using birth control or menopausal
  • Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

  • Pregnant or given birth in the last 6 months
  • Three or more urinary tract infections a year
  • Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
  • History of bladder cancer, ulcerative colitis or severe constipation
  • Any contraindication to vaginal delivery systems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: DR-3001a
4mg daily vaginally
Experimental: 2
Drug: DR-3001b
6 mg vaginally daily
Placebo Comparator: 3
Other: Placebo
Administered vaginally to match experimental arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the total weekly number of incontinence episodes
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Baseline to Treatment Week 12/Premature Discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
Average daily urinary frequency
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency
Time Frame: Baseline to Treatment Week 12/Premature Discontinuation
Baseline to Treatment Week 12/Premature Discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Investigators

  • Principal Investigator: Medical Monitor, Duramed Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 20, 2012

Last Update Submitted That Met QC Criteria

August 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-OXY-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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