A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: DR-3001; Drug: DR-3001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1104
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: DR-3001; 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks; Other Names: Oxybutinyn Vaginal Ring; Drug: DR-3001; 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks; Other Names: Oxybutinyn Vaginal Ring
EXPERIMENTAL: 2	Drug: DR-3001; 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks; Other Names: Oxybutinyn Vaginal Ring; Drug: DR-3001; 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks; Other Names: Oxybutinyn Vaginal Ring
PLACEBO_COMPARATOR: 3	Drug: Placebo; Placebo vaginal ring inserted vaginally and replaced every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total weekly number of incontinence (urge and stress)episodes	Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duramed Research

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (ESTIMATE): May 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: DR-OXY-301