Urinary IncontinencePhase 2NCT00196404
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
A Phase 2 study testing DR-3001a and DR-3001b in people with Urinary Incontinence, run by Duramed Research at 48 sites in 2 countries.
Trial summary
This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- DR-3001a and DR-3001b
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Oct 2004to Dec 2006
- Phase
- Phase 2
- 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
- Diagnosis of overactive bladder and incontinence for at least 6 months
- Using birth control or menopausal
- Willing to discontinue current medication for overactive bladder
Who cannot join
- Pregnant or given birth in the last 6 months
- Three or more urinary tract infections a year
- Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
- History of bladder cancer, ulcerative colitis or severe constipation
- Any contraindication to vaginal delivery systems
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States46 sites
Duramed Investigational Site
Aurora, Colorado, 80012
Duramed Investigational Site
Aventura, Florida, 33180
Duramed Investigational Site
Birmingham, Alabama, 35209
Duramed Investigational Site
Boise, Idaho, 83712
Duramed Investigational Site
Boise, Indiana, 83705
Duramed Investigational Site
Charleston, South Carolina, 29425
Duramed Research Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Dallas, Texas, 75234
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Denver, Colorado, 80220
Duramed Investigational Site
Edison, New Jersey, 08837
Duramed Investigational Site
Evansville, Indiana, 47714
Duramed Investigational Site
Fort Wayne, Indiana, 46825
Duramed Research Site
Gainesville, Florida, 32607
Duramed Research Site
Houston, Texas, 77024
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Indianapolis, Indiana, 46202
Duramed Investigational Site
Jackson, Mississippi, 39202
Duramed Investigational Site
Jackson, Tennessee, 38305
Duramed Investigational Site
Jeffersonville, Indiana, 47130
Duramed Investigational Site
Lancaster, Pennsylvania, 17604
Duramed Investigational Site
Lebanon, New Hampshire, 03756
Duramed Investigational Site
Little Rock, Arkansas, 72205
Duramed Investigational Site
Livingston, New Jersey, 07039
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Meridian, Indiana, 83642
Duramed Investigational Site
Milwaukee, Wisconsin, 53209
Duramed Investigational Site
Mobile, Alabama, 36608
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
Nashville, Tennessee, 37232
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Research Site
Phoenix, Arizona, 85015
Duramed Investigational Site
Portland, Oregon, 97210
Duramed Investigational Site
Providence, Rhode Island, 02904
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92108
Duremed Research Site
San Diego, California, 92108
Duramed Research Site
Sandy Springs, Georgia, 30328
Duramed Investigational Site
Seattle, Washington, 98105
Duramed Investigational Site
Shreveport, Louisiana, 71106
Duramed Research Site
Tacoma, Washington, 98405
Duramed Research Site
Tucson, Arizona, 85712
Duramed Research Site
Waco, Texas, 76712
Duramed Investigational Site
Waterbury, Connecticut, 06708
Duramed Investigational Site
Williamsville, New York, 14221
Canada2 sites
Duramed Investigational Site
Toronto, Ontario, M4N3M5
Duramed Investigational Site
Vancouver, British Columbia, V6T2B5
About this study
Official title: A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency
Read the detailed description
This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes
- Conditions
- Urinary Incontinence
- Being tested
- DR-3001a, DR-3001b, Placebo
- Keywords
- overactive bladder, urge incontinence, urinary incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-3001aDrug
4mg daily vaginally
DR-3001bDrug
6 mg vaginally daily
PlaceboOther
Administered vaginally to match experimental arms
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DR-3001a |
| 2 | Experimental | Not described Receives: Drug: DR-3001b |
| 3 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total weekly number of incontinence episodes
Measured: Baseline to Treatment Week 12/Premature Discontinuation
Secondary outcomes (4)
Average daily urinary frequency
Measured: Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Measured: Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Measured: Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency
Measured: Baseline to Treatment Week 12/Premature Discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Principal investigator, Duramed Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196404
- Sponsor's protocol ID
- BR-OXY-202
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00196404
- Acronym / sponsor ID
- BR-OXY-202
- Conditions
- Urinary Incontinence
- Keywords
- overactive bladder, urge incontinence, urinary incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (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 placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency
Detailed description
This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes
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-3001a |
| 2 | Experimental | Drug: DR-3001b |
| 3 | Placebo comparator | Other: Placebo |
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)
- Diagnosis of overactive bladder and incontinence for at least 6 months
- Using birth control or menopausal
- Willing to discontinue current medication for overactive bladder
Key exclusion criteria (5 listed)
- Pregnant or given birth in the last 6 months
- Three or more urinary tract infections a year
- Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
- History of bladder cancer, ulcerative colitis or severe constipation
- Any contraindication to vaginal delivery systems
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-3001a4mg daily vaginally | Drug | 1 |
| DR-3001b6 mg vaginally daily | Drug | 2 |
| PlaceboAdministered vaginally to match experimental arms | Other | 3 |
Primary outcome
Change in the total weekly number of incontinence episodes
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
4 secondary outcomes
Average daily urinary frequency
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency
Time frame: Baseline to Treatment Week 12/Premature Discontinuation
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 Aug 2012.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- MedLine Plus - Urinary IncontinenceLink provided by the sponsor.
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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.
Medical Monitor principal investigator
Duramed Research
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DR-3001a and DR-3001b in people with Urinary Incontinence, run by Duramed Research at 48 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 3 inclusion and 5 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the total weekly number of incontinence episodes (time frame: Baseline to Treatment Week 12/Premature Discontinuation). 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 NCT00196404, which also lists 1 linked publication.
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 Aug 2012.