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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196404
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Urinary Incontinence
Drug: DR-3001a
Drug: DR-3001b
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in the total weekly number of incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily urinary frequency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Proportion of patients with no incontinence episodes [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Average void volume [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]
  • Average severity of urgency [ Time Frame: Baseline to Treatment Week 12/Premature Discontinuation ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196404

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

Additional Information:
No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00196404     History of Changes
Other Study ID Numbers: BR-OXY-202
Study First Received: September 13, 2005
Last Updated: August 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
overactive bladder
urge incontinence
urinary incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014