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

NCT00685113 | Completed Phase 3

• 1 other identifier: DR-OXY-301
• Study Type: interventional
• Target: 1,104
• Locations: 2 countries
• Sites: 84

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change in total weekly number of incontinence (urge and stress)episodes

  Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary Outcomes (4)

• 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)

Study Arms (3)

1

EXPERIMENTAL

Drug: DR-3001

2

EXPERIMENTAL

Drug: DR-3001

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DR-3001 DRUG

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

Also known as: Oxybutinyn Vaginal Ring

1

Placebo DRUG

Placebo vaginal ring inserted vaginally and replaced every 4 weeks

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duramed Research: lead

Study Sites (84)

Duramed Investigational Site

Huntsville, Alabama, 35801, United States

Location

Duramed Investigational Site

Mobile, Alabama, 36608, United States

Location

Duramed Investigational Site

Montgomery, Alabama, 36116, United States

Location

Duramed Investigational Site

Phoenix, Arizona, 85015, United States

Location

Duramed Investigational Site

Tucson, Arizona, 85712, United States

Location

Duramed Investigational Site

Tucson, Arizona, 85741, United States

Location

Duramed Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Duramed Investigational Site

Encinitas, California, 92024, United States

Location

Duramed Investigational Site

Los Angeles, California, 90036, United States

Location

Duramed Investigational Site

San Diego, California, 92103, United States

Location

Duramed Investigational Site

San Diego, California, 92108, United States

Location

Duramed Investigational Site

San Diego, California, 92123, United States

Location

Duramed Investigational Site

Colorado Springs, Colorado, 80909, United States

Location

Duramed Investigational Site

Denver, Colorado, 80220, United States

Location

Duramed Investigational Site

Danbury, Connecticut, 06810, United States

Location

Duramed Investigational Site

Milford, Connecticut, 06460, United States

Location

Duramed Investigational Site

New London, Connecticut, 06320, United States

Location

Duramed Investigational Site

Aventura, Florida, 33180, United States

Location

Duramed Investigational Site

Gainesville, Florida, 32607, United States

Location

Duramed Investigational Site

Jacksonville, Florida, 32207, United States

Location

Duramed Investigational Site

Miami, Florida, 33143, United States

Location

Duramed Investigational Site

New Port Richey, Florida, 34655, United States

Location

Duramed Investigational Site

Tampa, Florida, 33607, United States

Location

Duramed Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Duramed Investigational Site

West Palm Beach, Florida, 33409, United States

Location

Duramed Investigational Site

Atlanta, Georgia, 30308, United States

Location

Duramed Investigational Site

Augusta, Georgia, 30901, United States

Location

Duramed Investigation Site

Decatur, Georgia, 30034, United States

Location

Duramed Investigational Site

Savannah, Georgia, 31406, United States

Location

Duramed Investigational Site

Boise, Idaho, 83704, United States

Location

Duramed Investigational Site

Boise, Idaho, 83712, United States

Location

Duramed Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

Duramed Investigational Site

Meridian, Idaho, 83642, United States

Location

Duramed Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Duramed Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

Duramed Investigational Site

South Bend, Indiana, 46601, United States

Location

Duramed Investigational Site

Newton, Kansas, 67114, United States

Location

Duramed Investigational Site

Wichita, Kansas, 67207, United States

Location

Duramed Investigational Site

Louisville, Kentucky, 40291, United States

Location

Duramed Investigational Site

Lafayette, Louisiana, 70503, United States

Location

Duramed Investigational Site

Marrero, Louisiana, 70072, United States

Location

Duramed Investigational Site

Shreveport, Louisiana, 71106, United States

Location

Duramed Investigational Site

Watertown, Massachusetts, 02472, United States

Location

Duramed Investigational Site

Las Vegas, Nevada, 89109, United States

Location

Duramed Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Duramed Investigational Site

North Las Vegas, Nevada, 89030, United States

Location

Duramed Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

Duramed Investigational Site

Lawrenceville, New Jersey, 08648, United States

Location

Duramed Investigational Site

Moorestown, New Jersey, 08057, United States

Location

Duramed Investigational Site

New Brunswick, New Jersey, 08901, United States

Location

Duramed Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Duramed Investigational Site

Port Jefferson, New York, 11777, United States

Location

Duramed Investigational Site

New Bern, North Carolina, 28562, United States

Location

Duramed Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Duramed Investigational Site

Cleveland, Ohio, 44122, United States

Location

Duramed Investigational Site

Mayfield Heights, Ohio, 44124, United States

Location

Duramed Investigational Site

Bethany, Oklahoma, 73008, United States

Location

Duramed Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Duramed Investigational Site

Eugene, Oregon, 97401, United States

Location

Duramed Investigational Site

Medford, Oregon, 97504, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Duramed Investigational Site

Pittsburgh, Pennsylvania, 15206, United States

Location

Duramed Investigational Site

Pottstown, Pennsylvania, 19464, United States

Location

Duramed Investigational Site

Charlestown, South Carolina, 29425, United States

Location

Duramed Investigational Site

Columbia, South Carolina, 29201, United States

Location

Duramed Investigational Site

Greensville, South Carolina, 29605, United States

Location

Duramed Investigational Site

Hilton Head Island, South Carolina, 29926, United States

Location

Duramed Investigational Site

Jackson, Tennessee, 38305, United States

Location

Duramed Investigational Site

Dallas, Texas, 75234, United States

Location

Duramed Investigational Site

Dallas, Texas, 75390, United States

Location

Duramed Investigational Site

Dallas, Texas, 78229, United States

Location

Duramed Investigational Site

Houston, Texas, 77024, United States

Location

Duramed Investigational Site

San Antonio, Texas, 78209, United States

Location

Duramed Investigational Site

San Antonio, Texas, 78229, United States

Location

Duramed Investigational Site

Waco, Texas, 76712, United States

Location

Duramed Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Duramed Investigational Site

Williston, Vermont, 05495, United States

Location

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

Location

Duramed Investigational Site

Seattle, Washington, 98105, United States

Location

Duramed Investigational Site

Tacoma, Washington, 98405, United States

Location

Duramed Investigatinal Site

Vancouver, British Columbia, V6T 2B5, Canada

Location

Duramed Investigational Site

Oshawa, Ontario, L1H 7K4, Canada

Location

Duramed Investigational Site

Thunder Bay, Ontario, P7E 6E7, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duramed Research Protocol Chair

  Duramed Research, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

CA (3); US (81)