Overactive BladderPhase 3NCT00685113

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

A Phase 3 study testing DR-3001 in people with Overactive Bladder, run by Duramed Research at 84 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Overactive Bladder
What is being tested?: DR-3001
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,104 participants
Where: 84 sitesin 2 countries
Study dates: May 2008to Mar 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

84 sites in 2 countries.

Country

City, postcode or hospital

84 sites in 2 countries

United States81 sites

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

Other trials in United States

Canada3 sites

Duramed Investigational Site
Oshawa, Ontario, L1H 7K4
Duramed Investigational Site
Thunder Bay, Ontario, P7E 6E7
Duramed Investigatinal Site
Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: 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.

Conditions: Overactive Bladder
Being tested: DR-3001, Placebo
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DR-3001Drug
Also called Oxybutinyn Vaginal Ring
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
DR-3001Drug
Also called Oxybutinyn Vaginal Ring
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
PlaceboDrug
Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Study groups in NCT00685113
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: DR-3001
2	Experimental	Not described Receives: Drug: DR-3001
3	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in total weekly number of incontinence (urge and stress)episodes
Measured: Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Mar 2010

First posted28 May 2008 (estimated)
Study startMay 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00685113
Sponsor's protocol ID: DR-OXY-301
Status last verified: Jul 2016
First submitted: 23 May 2008
Last updated: 20 Jul 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00685113
Acronym / sponsor ID: DR-OXY-301
Conditions: Overactive Bladder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,104 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 28 May 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: DR-3001
2	Experimental	Drug: DR-3001
3	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DR-3001Also: Oxybutinyn Vaginal Ring4mg/day vaginal ring inserted vaginally and replaced every 4 weeks	Drug	1
DR-3001Also: Oxybutinyn Vaginal Ring6mg/day vaginal ring inserted vaginally and replaced every 4 weeks	Drug	2
PlaceboPlacebo vaginal ring inserted vaginally and replaced every 4 weeks	Drug	3

Primary outcome

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

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.

Related trials for Overactive Bladder

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duramed Research Protocol Chair study chair

Duramed Research, Inc.

84 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DR-3001 in people with Overactive Bladder, run by Duramed Research at 84 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total weekly number of incontinence (urge and stress)episodes (time frame: Baseline to end-of-treamtent (Week 12/Early withdrawal)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.