Urinary Bladder, OveractivePhase 3VENUSNCT00454896
A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)
A Phase 3 study testing VESIcare® in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 65 sites in United States.
Trial summary
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- VESIcare®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 739 participants
- Where
- 65 sitesUnited States
- Study dates
- May 2004to Sep 2005
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
- Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.
Who cannot join
- Previous treatment with darifenacin
- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
- Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Study site
Albany, New York, 12205
Study site
Albuquerque, New Mexico, 87108
Study site
Alpharetta, Georgia, 30005
Study site
Athens, Texas, 75751
Study site
Atherton, California, 94027
Study site
Atlanta, Georgia, 30342
Study site
Aurora, Colorado, 80012
Study site
Billings, Montana, 59102
Study site
Bismarck, North Dakota, 58501
Study site
Bloomfield Hills, Michigan, 48302
Study site
Blue Ridge, Georgia, 30513
Study site
Boise, Idaho, 83702
Study site
Boyton Beach, Florida, 33347
Study site
Carmichael, California, 95608
Study site
Centralia, Illinois, 62801
Study site
Chesterfield, Missouri, 63017
Study site
Cincinnati, Ohio, 45220
Study site
Clearwater, Florida, 33761
Study site
Clearwater, Florida, 33765
Study site
Cleveland, Ohio, 44195
Study site
Concord, North Carolina, 28025
Study site
Denver, Colorado, 80205
Study site
East Syracuse, New York, 13057
Study site
Endwell, Pennsylvania, 13760
Study site
Escondido, California, 72025
Study site
Eugene, Oregon, 97401
Study site
Fresno, California, 93703
Study site
Gainesville, Florida, 32607
Study site
Hewlett, New York, 11551
Study site
Hickory, North Carolina, 28601
Study site
Lawrenceville, New Jersey, 08648
Study site
Lewiston, New York, 14092
Study site
Los Angeles, California, 90057
Study site
Marietta, Georgia, 30060
Study site
Media, Pennsylvania, 19063
Study site
Mission Hills, California, 91345
Study site
Mission Viejo, California, 92691
Study site
Monroeville, Pennsylvania, 15146
Study site
Morgantown, West Virginia, 26506
Study site
Mt. Pleasant, South Carolina, 29464
Study site
New London, Connecticut, 06320
Study site
New York, New York, 10021
Study site
Norwalk, Connecticut, 06850
Study site
Ogden, Utah, 84403
Study site
Pembroke Pines, Florida, 33027
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85032
Study site
Plantation, Florida, 33324
Study site
Richmond, Virginia, 23294
Study site
Salinas, California, 93901
Study site
Scottsdale, Arizona, 85258
Study site
Slidell, Louisiana, 70461
Study site
South Bound Brook, New Jersey, 08880
Study site
Spokane, Washington, 99202
Study site
St Louis, Missouri, 63117
Study site
St Louis, Missouri, 63128
Study site
Tallahassee, Florida, 32308
Study site
Trumbull, Connecticut, 06611
Study site
Uniontown, Pennsylvania, 15401
Study site
Valley Village, California, 91607
Study site
Vancouver, Washington, 98607
Study site
Washington D.C., District of Columbia, 20017
Study site
Waterbury, Connecticut, 06708
Study site
West Point, Utah, 84015
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- VESIcare®, placebo
- Keywords
- Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
- 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.
VESIcare®Drug
Also called solifenacin succinate, YM905
Oral
placeboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: VESIcare® |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome
Measured: Weeks 1, 4, 8 and 12
Secondary outcomes (5)
Improvement of urgency
Measured: Weeks 1, 4, 8 and 12
Improvement of frequency, incontinence and nocturia
Measured: Weeks 1, 4, 8 and 12
Number of patients satisfied with treatment
Measured: Weeks 1, 4, 8 and 12
Assessment of the efficacy
Measured: End of study
Evaluation of the safety and tolerability
Measured: Baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMay 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454896
- Sponsor's protocol ID
- 905-UC-005
- Acronym
- VENUS
- Status last verified
- Sep 2014
- First submitted
- 29 Mar 2007
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
PubMed 18995887Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.
PubMed 19820284Stoniute 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 37160401Serels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582.
PubMed 20707767
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00454896
- Acronym / sponsor ID
- VENUS / 905-UC-005
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 2 Apr 2007 (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.
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VESIcare® |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
- Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.
Key exclusion criteria (5 listed)
- Previous treatment with darifenacin
- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
- Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator
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 |
|---|---|---|
| VESIcare®Also: solifenacin succinate, YM905Oral | Drug | 1 |
| placeboOral | Drug | 2 |
Primary outcome
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome
Time frame: Weeks 1, 4, 8 and 12
5 secondary outcomes
Improvement of urgency
Time frame: Weeks 1, 4, 8 and 12
Improvement of frequency, incontinence and nocturia
Time frame: Weeks 1, 4, 8 and 12
Number of patients satisfied with treatment
Time frame: Weeks 1, 4, 8 and 12
Assessment of the efficacy
Time frame: End of study
Evaluation of the safety and tolerability
Time frame: Baseline to end 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 18 Sep 2014.
- Background: PubMed 18995887Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
- Background: PubMed 19820284Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.
- 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.
- Derived from this study: PubMed 20707767Serels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
65 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 VESIcare® in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 65 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 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 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. 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?
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome (time frame: Weeks 1, 4, 8 and 12). 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 NCT00454896, which also lists 4 linked publications.
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 18 Sep 2014.