MedDataX Logo

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

NCT ID: NCT00685113

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00196404

Urinary Incontinence
COMPLETED PHASE2

A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

NCT00171145

Overactive Bladder Syndrome
COMPLETED PHASE3

A Safety Extension Study of DR-OXY-301

NCT00782769

Overactive Bladder
COMPLETED PHASE3

A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder

NCT00321477

Incontinence, Urinary and Urinary Bladder, Overactive Overactive Bladder
COMPLETED PHASE2

Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

NCT00171184

Overactive Bladder
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

DR-3001

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

DR-3001

Intervention Type DRUG

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

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DR-3001

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

Intervention Type DRUG

DR-3001

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

Intervention Type DRUG

Placebo

Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oxybutinyn Vaginal Ring Oxybutinyn Vaginal Ring

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duramed Research Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duramed Investigational Site

Huntsville, Alabama, United States

Site Status

Duramed Investigational Site

Mobile, Alabama, United States

Site Status

Duramed Investigational Site

Montgomery, Alabama, United States

Site Status

Duramed Investigational Site

Phoenix, Arizona, United States

Site Status

Duramed Investigational Site

Tucson, Arizona, United States

Site Status

Duramed Investigational Site

Tucson, Arizona, United States

Site Status

Duramed Investigational Site

Little Rock, Arkansas, United States

Site Status

Duramed Investigational Site

Encinitas, California, United States

Site Status

Duramed Investigational Site

Los Angeles, California, United States

Site Status

Duramed Investigational Site

San Diego, California, United States

Site Status

Duramed Investigational Site

San Diego, California, United States

Site Status

Duramed Investigational Site

San Diego, California, United States

Site Status

Duramed Investigational Site

Colorado Springs, Colorado, United States

Site Status

Duramed Investigational Site

Denver, Colorado, United States

Site Status

Duramed Investigational Site

Danbury, Connecticut, United States

Site Status

Duramed Investigational Site

Milford, Connecticut, United States

Site Status

Duramed Investigational Site

New London, Connecticut, United States

Site Status

Duramed Investigational Site

Aventura, Florida, United States

Site Status

Duramed Investigational Site

Gainesville, Florida, United States

Site Status

Duramed Investigational Site

Jacksonville, Florida, United States

Site Status

Duramed Investigational Site

Miami, Florida, United States

Site Status

Duramed Investigational Site

New Port Richey, Florida, United States

Site Status

Duramed Investigational Site

Tampa, Florida, United States

Site Status

Duramed Investigational Site

West Palm Beach, Florida, United States

Site Status

Duramed Investigational Site

West Palm Beach, Florida, United States

Site Status

Duramed Investigational Site

Atlanta, Georgia, United States

Site Status

Duramed Investigational Site

Augusta, Georgia, United States

Site Status

Duramed Investigation Site

Decatur, Georgia, United States

Site Status

Duramed Investigational Site

Savannah, Georgia, United States

Site Status

Duramed Investigational Site

Boise, Idaho, United States

Site Status

Duramed Investigational Site

Boise, Idaho, United States

Site Status

Duramed Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

Duramed Investigational Site

Meridian, Idaho, United States

Site Status

Duramed Investigational Site

Fort Wayne, Indiana, United States

Site Status

Duramed Investigational Site

Jeffersonville, Indiana, United States

Site Status

Duramed Investigational Site

South Bend, Indiana, United States

Site Status

Duramed Investigational Site

Newton, Kansas, United States

Site Status

Duramed Investigational Site

Wichita, Kansas, United States

Site Status

Duramed Investigational Site

Louisville, Kentucky, United States

Site Status

Duramed Investigational Site

Lafayette, Louisiana, United States

Site Status

Duramed Investigational Site

Marrero, Louisiana, United States

Site Status

Duramed Investigational Site

Shreveport, Louisiana, United States

Site Status

Duramed Investigational Site

Watertown, Massachusetts, United States

Site Status

Duramed Investigational Site

Las Vegas, Nevada, United States

Site Status

Duramed Investigational Site

Las Vegas, Nevada, United States

Site Status

Duramed Investigational Site

North Las Vegas, Nevada, United States

Site Status

Duramed Investigational Site

Lebanon, New Hampshire, United States

Site Status

Duramed Investigational Site

Lawrenceville, New Jersey, United States

Site Status

Duramed Investigational Site

Moorestown, New Jersey, United States

Site Status

Duramed Investigational Site

New Brunswick, New Jersey, United States

Site Status

Duramed Investigational Site

Albuquerque, New Mexico, United States

Site Status

Duramed Investigational Site

Port Jefferson, New York, United States

Site Status

Duramed Investigational Site

New Bern, North Carolina, United States

Site Status

Duramed Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Duramed Investigational Site

Cleveland, Ohio, United States

Site Status

Duramed Investigational Site

Mayfield Heights, Ohio, United States

Site Status

Duramed Investigational Site

Bethany, Oklahoma, United States

Site Status

Duramed Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Duramed Investigational Site

Eugene, Oregon, United States

Site Status

Duramed Investigational Site

Medford, Oregon, United States

Site Status

Duramed Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Duramed Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Duramed Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Duramed Investigational Site

Pottstown, Pennsylvania, United States

Site Status

Duramed Investigational Site

Charlestown, South Carolina, United States

Site Status

Duramed Investigational Site

Columbia, South Carolina, United States

Site Status

Duramed Investigational Site

Greensville, South Carolina, United States

Site Status

Duramed Investigational Site

Hilton Head Island, South Carolina, United States

Site Status

Duramed Investigational Site

Jackson, Tennessee, United States

Site Status

Duramed Investigational Site

Dallas, Texas, United States

Site Status

Duramed Investigational Site

Dallas, Texas, United States

Site Status

Duramed Investigational Site

Dallas, Texas, United States

Site Status

Duramed Investigational Site

Houston, Texas, United States

Site Status

Duramed Investigational Site

San Antonio, Texas, United States

Site Status

Duramed Investigational Site

San Antonio, Texas, United States

Site Status

Duramed Investigational Site

Waco, Texas, United States

Site Status

Duramed Investigational Site

Salt Lake City, Utah, United States

Site Status

Duramed Investigational Site

Williston, Vermont, United States

Site Status

Duramed Investigational Site

Norfolk, Virginia, United States

Site Status

Duramed Investigational Site

Seattle, Washington, United States

Site Status

Duramed Investigational Site

Tacoma, Washington, United States

Site Status

Duramed Investigatinal Site

Vancouver, British Columbia, Canada

Site Status

Duramed Investigational Site

Oshawa, Ontario, Canada

Site Status

Duramed Investigational Site

Thunder Bay, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DR-OXY-301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
NCT04211831 COMPLETED PHASE2
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
NCT00366002 COMPLETED PHASE4
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
NCT02216214 COMPLETED PHASE4
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
NCT02821312 UNKNOWN PHASE1
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT00911937 COMPLETED PHASE4
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00688688 COMPLETED PHASE3
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00912964 COMPLETED PHASE3
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00689104 COMPLETED PHASE3
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
NCT00170755 COMPLETED PHASE3
A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
NCT00231790 COMPLETED PHASE2
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
NCT00290563 COMPLETED PHASE2
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
NCT00928070 COMPLETED PHASE4
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
NCT00768521 COMPLETED PHASE1
OnabotulinumtoxinA Bladder Injection Study
NCT03523091 TERMINATED PHASE4
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
NCT00645281 COMPLETED PHASE4
Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
NCT01868516 COMPLETED PHASE2
Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects
NCT01029015 COMPLETED
A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)
NCT01099345 TERMINATED
Study of V117957 in Overactive Bladder Syndrome
NCT06024642 COMPLETED PHASE1
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
NCT00139724 COMPLETED PHASE3
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
NCT00127270 COMPLETED PHASE4
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
NCT00662909 COMPLETED PHASE3
Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
NCT05719285 COMPLETED PHASE4
Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
NCT02485067 COMPLETED PHASE3
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
NCT00335660 TERMINATED PHASE2