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

Sponsors

Lead Sponsor: Duramed Research

Source Teva Pharmaceutical Industries
Brief Summary

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.

Overall Status Completed
Start Date 2008-05-01
Completion Date 2010-03-01
Primary Completion Date 2010-03-01
Phase Phase 3
Study Type Interventional
Primary 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
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)
Enrollment 1104
Condition
Intervention

Intervention Type: Drug

Intervention Name: DR-3001

Description: 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks

Arm Group Label: 1

Other Name: Oxybutinyn Vaginal Ring

Intervention Type: Drug

Intervention Name: DR-3001

Description: 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks

Arm Group Label: 2

Other Name: Oxybutinyn Vaginal Ring

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Arm Group Label: 3

Eligibility

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

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

Canada

United States

Verification Date

2016-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Experimental

Label: 3

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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