Overactive BladderPhase 3NCT00782769
A Safety Extension Study of DR-OXY-301
A Phase 3 study testing Oxybutinyn Vaginal Ring 4mg and Oxybutinyn Vaginal Ring 6mg in people with Overactive Bladder, run by Duramed Research at 35 sites in United States.
Trial summary
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Oxybutinyn Vaginal Ring 4mg and Oxybutinyn Vaginal Ring 6mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 35 sitesUnited States
- Study dates
- Sep 2008to Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the 12 weeks of treatment in the DR-OXY-301 study
- Willing to limit medications for overactive bladder to investigational product only
- Able to understand and complete all study procedures including the required diary
Who cannot join
None listed.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Duramed Investigational Site
Albuquerque, New Mexico, 87102
Duramed Investigational Site
Augusta, Georgia, 30901
Duramed Investigational Site
Boise, Idaho, 83712
Duramed Investigational Site
Chicago, Illinois, 60661-3095
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Eugene, Oregon, 97401
Duramed Investigational Site
Hilton Head Island, South Carolina, 29926
Duramed Investigational Site
Houston, Texas, 77024
Duramed Investigational Site
Jackson, Tennessee, 38305
Duramed Investigational Site
Las Vegas, Nevada, 89030
Duramed Investigational Site
Las Vegas, Nevada, 89109
Duramed Investigational Site
Las Vegas, Nevada, 89128
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
New Bern, North Carolina, 28562
Duramed Investigational Site
Norfolk, Virginia, 23507
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
San Diego, California, 92103
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
Savannah, Georgia, 31406
Duramed Investigational Site
Seattle, Washington, 98105
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tampa, Florida, 33607
Duramed Investigational Site
Waco, Texas, 76712
Duramed Investigational Site
Watertown, Massachusetts, 02472
Duramed Investigational Site
Wichita, Kansas, 67207
Duramed Investigational Site
Williston, Vermont, 05495
About this study
Official title: A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
- Conditions
- Overactive Bladder
- Being tested
- Oxybutinyn Vaginal Ring 4mg, Oxybutinyn Vaginal Ring 6mg
- 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.
Oxybutinyn Vaginal Ring 4mgDrug
Also called DR-3001
Oxybutinyn Vaginal Ring 6mgDrug
Also called DR-3001
| Study group | Role | What they receive |
|---|---|---|
| Oxybutinyn Vaginal Ring 4mg | Experimental | inserted daily and replaced every 4 weeks Receives: Drug: Oxybutinyn Vaginal Ring 4mg |
| Oxybutinyn Vaginal Ring 6mg | Experimental | inserted daily and replaced every 4 weeks Receives: Drug: Oxybutinyn Vaginal Ring 6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionJul 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duramed Research Protocol Chair, Study chair, Duramed Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782769
- Sponsor's protocol ID
- DR-OXY-302
- Status last verified
- Mar 2023
- First submitted
- 29 Oct 2008
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00782769
- Acronym / sponsor ID
- DR-OXY-302
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 Oct 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.
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxybutinyn Vaginal Ring 4mg | Experimental | Drug: Oxybutinyn Vaginal Ring 4mginserted daily and replaced every 4 weeks |
| Oxybutinyn Vaginal Ring 6mg | Experimental | Drug: Oxybutinyn Vaginal Ring 6mginserted daily and replaced every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed the 12 weeks of treatment in the DR-OXY-301 study
- Willing to limit medications for overactive bladder to investigational product only
- Able to understand and complete all study procedures including the required diary
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oxybutinyn Vaginal Ring 4mgAlso: DR-3001 | Drug | Oxybutinyn Vaginal Ring 4mg |
| Oxybutinyn Vaginal Ring 6mgAlso: DR-3001 | Drug | Oxybutinyn Vaginal Ring 6mg |
Primary outcome
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Time frame: Duration of Study
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 16 Mar 2023.
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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
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybutinyn Vaginal Ring 4mg and Oxybutinyn Vaginal Ring 6mg in people with Overactive Bladder, run by Duramed Research at 35 sites in United States.
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 3 inclusion and 0 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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. 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?
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported (time frame: Duration of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.