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A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
This study is ongoing, but not recruiting participants.
First Received: May 23, 2008   Last Updated: October 15, 2009   History of Changes
Sponsor: Duramed Research
Information provided by: Duramed Research
ClinicalTrials.gov Identifier: NCT00685113
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
 Drug: DR-3001
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of DR-3001 Versus Placebo in Women With Overactive Bladder

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence
U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Change in total weekly number of incontinence (urge and stress)episodes [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average daily urinary frequency and average void volume [ Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal) ] [ Designated as safety issue: No ]
  • Proportion of subjects with no incontinence episodes recorded in the final 3-day diary [ Time Frame: Final 3-day diary ] [ Designated as safety issue: No ]
  • 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question [ Time Frame: Baseline to end-of-treatment (Week 12/Early Withdrawal) ] [ Designated as safety issue: No ]
  • Adverse events (AEs) reported by subjects or identified by the investigator [ Time Frame: Basline to end-of-treatment (Week 12/Early Withdrawal) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1161
Study Start Date: May 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
2: Experimental Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
3: Placebo Comparator Drug: Placebo
Placebo vaginal ring inserted vaginally and replaced every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months
  • Able to distinguish between stress and urge incontinence
  • During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries
  • Others as dictated by FDA-approved protocol

Exclusion Criteria:

  • Stress incontinence, continuous incontinence or overflow urinary incontinence
  • Chronic illness, neurological dysfunction or injury that could cause incontinence
  • Pregnant, breastfeeding, or gave birth in the last 6 months
  • Others as dictated by FDA-approved protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685113

  Hide Study Locations
Locations
United States, Alabama
Duramed Investigational Site
Montgomery, Alabama, United States, 36116
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
Duramed Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Duramed Investigational Site
Tucson, Arizona, United States, 85712
Duramed Investigational Site
Phoenix, Arizona, United States, 85015
Duramed Investigational Site
Tucson, Arizona, United States, 85741
United States, Arkansas
Duramed Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Duramed Investigational Site
San Diego, California, United States, 92103
Duramed Investigational Site
San Diego, California, United States, 92108
Duramed Investigational Site
San Diego, California, United States, 92123
Duramed Investigational Site
Encinitas, California, United States, 92024
Duramed Investigational Site
Los Angeles, California, United States, 90036
United States, Colorado
Duramed Investigational Site
Colorado Springs, Colorado, United States, 80909
Duramed Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
Duramed Investigational Site
Milford, Connecticut, United States, 06460
Duramed Investigational Site
New London, Connecticut, United States, 06320
Duramed Investigational Site
Danbury, Connecticut, United States, 06810
United States, Florida
Duramed Investigational Site
West Palm Beach, Florida, United States, 33409
Duramed Investigational Site
Miami, Florida, United States, 33143
Duramed Investigational Site
Aventura, Florida, United States, 33180
Duramed Investigational Site
Gainesville, Florida, United States, 32607
Duramed Investigational Site
New Port Richey, Florida, United States, 34655
Duramed Investigational Site
Tampa, Florida, United States, 33607
Duramed Investigational Site
West Palm Beach, Florida, United States, 33407
Duramed Investigational Site
Jacksonville, Florida, United States, 32207
United States, Georgia
Duramed Investigational Site
Augusta, Georgia, United States, 30901
Duramed Investigational Site
Atlanta, Georgia, United States, 30308
Duramed Investigation Site
Decatur, Georgia, United States, 30034
Duramed Investigational Site
Savannah, Georgia, United States, 31406
United States, Idaho
Duramed Investigational Site
Coeur d'Alene, Idaho, United States, 83814
Duramed Investigational Site
Meridian, Idaho, United States, 83642
Duramed Investigational Site
Boise, Idaho, United States, 83712
Duramed Investigational Site
Boise, Idaho, United States, 83704
United States, Indiana
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Jeffersonville, Indiana, United States, 47130
Duramed Investigational Site
South Bend, Indiana, United States, 46601
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Fort Wayne, Indiana, United States, 46825
United States, Kansas
Duramed Investigational Site
Wichita, Kansas, United States, 67207
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Newton, Kansas, United States, 67114
United States, Kentucky
Duramed Investigational Site
Louisville, Kentucky, United States, 40291
United States, Louisiana
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Shreveport, Louisiana, United States, 71106
Duramed Investigational Site
Marrero, Louisiana, United States, 70072
Duramed Investigational Site
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
Duramed Investigational Site
Watertown, Massachusetts, United States, 02472
United States, Nevada
Duramed Investigational Site
N. Las Vegas, Nevada, United States, 89030
Duramed Investigational Site
Las Vegas, Nevada, United States, 89128
Duramed Investigational Site
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Duramed Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Duramed Investigational Site
Lawrenceville, New Jersey, United States, 08648
Duramed Investigational Site
Moorestown, New Jersey, United States, 08057
Duramed Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Duramed Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Duramed Investigational Site
Port Jefferson, New York, United States, 11777
United States, North Carolina
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
Duramed Investigational Site
New Bern, North Carolina, United States, 28562
United States, Ohio
Duramed Investigational Site
Cleveland, Ohio, United States, 44122
Duramed Investigational Site
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Duramed Investigational Site
Bethany, Oklahoma, United States, 73008
Duramed Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Duramed Investigational Site
Eugene, Oregon, United States, 97401
Duramed Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Duramed Investigational Site
Pottstown, Pennsylvania, United States, 19464
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Duramed Investigational Site
Columbia, South Carolina, United States, 29201
Duramed Investigational Site
Hilton Head Island, South Carolina, United States, 29926
Duramed Investigational Site
Charlestown, South Carolina, United States, 29425
Duramed Investigational Site
Greensville, South Carolina, United States, 29605
United States, Tennessee
Duramed Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
Duramed Investigational Site
Dallas, Texas, United States, 75234
Duramed Investigational Site
Houston, Texas, United States, 77024
Duramed Investigational Site
San Antonio, Texas, United States, 78209
Duramed Investigational Site
Waco, Texas, United States, 76712
Duramed Investigational Site
San Antonio, Texas, United States, 78229
Duramed Investigational Site
Dallas, Texas, United States, 78229
Duramed Investigational Site
Dallas, Texas, United States, 75390
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Vermont
Duramed Investigational Site
Williston, Vermont, United States, 05495
United States, Virginia
Duramed Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Duramed Investigational Site
Seattle, Washington, United States, 98105
Duramed Investigational Site
Tacoma, Washington, United States, 98405
Canada, British Columbia
Duramed Investigatinal Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Duramed Investigational Site
Thunder Bay, Ontario, Canada, P7E 6E7
Duramed Investigational Site
Oshawa, Ontario, Canada, L1H 7K4
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Duramed Research, Inc ( Duramed Research, Inc )
Study ID Numbers: DR-OXY-301
Study First Received: May 23, 2008
Last Updated: October 15, 2009
ClinicalTrials.gov Identifier: NCT00685113     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on November 30, 2009



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