Urinary Bladder, OveractivePhase 4VIBRANTNCT00573508
Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
A Phase 4 study testing Solifenacin Succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 59 sites in United States.
Trial summary
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB 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?
- Solifenacin Succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- 59 sitesUnited States
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
- History of OAB symptoms for ≥ 3 months
- An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
- Subjects are bothered by symptoms as reflected by PPBC ≥3
Who cannot join
- Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
- Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
- History of diagnosed gastrointestinal obstruction disease
- Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
- Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Study site
Arlington, Texas, 76017
Study site
Aurora, Colorado, 80012
Study site
Austin, Texas, 78759
Study site
Bedford, Texas, 76021
Study site
Billings, Montana, 59102
Study site
Buena Park, California, 90620
Study site
Carmichael, California, 95608
Study site
Central Point, Oregon, 97502
Study site
Cincinnati, Ohio, 45212
Study site
Clearwater, Florida, 33761
Study site
Concord, North Carolina, 28025
Study site
Corpus Christi, Texas, 78414
Study site
Denver, Colorado, 80211
Study site
Denver, Colorado, 80220
Study site
Edmond, Oklahoma, 73034
Study site
Endwell, New York, 13760
Study site
Englewood, Colorado, 32308
Study site
Englewood, New Jersey, 07631
Study site
Fargo, North Dakota, 58104
Study site
Fresno, California, 93720
Study site
Garden City, New York, 11530
Study site
Greer, South Carolina, 29650
Study site
Houston, Texas, 77024
Study site
Idaho Falls, Idaho, 83404
Study site
Jeffersonville, Indiana, 47130
Study site
Kingston, New York, 12401
Study site
Lawrenceville, New Jersey, 08648
Study site
Lyndhurst, Ohio, 44124
Study site
Madison, Wisconsin, 53703
Study site
Melrose Park, Illinois, 60160
Study site
Montgomery, Alabama, 36067
Study site
Mount Lake, Washington, 98043
Study site
New York, New York, 10016
Study site
New York, New York, 10029
Study site
Omaha, Nebraska, 68114
Study site
Orchard Park, New York, 14127
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85051
Study site
Plantation, Florida, 33324
Study site
Poughkeepsie, New York, 12601
Study site
Raleigh, North Carolina, 27612
Study site
Roswell, Georgia, 30076
Study site
Sacramento, California, 95825
Study site
San Bernardino, California, 92404
Study site
San Diego, California, 92108
Study site
Shreveport, Louisiana, 71106
Study site
Simpsonville, South Carolina, 29681
Study site
Spokane, Washington, 99202
Study site
Tacoma, Washington, 98405
Study site
Tallahassee, Florida, 32308
Study site
Tampa, Florida, 33607
Study site
Tampa, Florida, 33613
Study site
Tucson, Arizona, 85741
Study site
Uniontown, Pennsylvania, 15401
Study site
Waterbury, Connecticut, 67080
Study site
Watertown, Massachusetts, 02472
Study site
Wellington, Florida, 33414
Study site
West Reading, Pennsylvania, 19611
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Read the detailed description
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.
The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.
Primary efficacy will be based on OAB-q symptom bother score.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Placebo, Solifenacin Succinate
- Keywords
- Overactive Bladder
- 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.
PlaceboDrug
Oral Administration
Solifenacin SuccinateDrug
Also called VESIcare®, YM905
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Matching placebo tablet taken once daily Receives: Drug: Placebo |
| Solifenacin Succinate | Experimental | 5mg or 10mg tablet taken once daily Receives: Drug: Solifenacin Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment - Baseline.
Measured: Baseline and 12 Weeks
Secondary outcomes (12)
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.
Change is calculated as Actual Data for each timepoint - Baseline.
Measured: Baseline, Week 4, Week 8 and Week 12
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100.
Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.
Change is calculated as Actual Data for each time point - Baseline.
Measured: Baseline, Week 4, Week 8 and Week 12
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems
Improvement is defined by any reduction in PPBC score.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline
Measured: Baseline and 12 Weeks
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.
Measured: Baseline and 12 Weeks
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.
Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.
Change is calculated End of Treatment (EOT) for each sub-domain - Baseline.
Measured: Baseline, Week 4, Week 8 and Week 12
Change From Baseline in Work Productivity Assessment Index (WPAI)
The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction \& quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions \& carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.
A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.
Change from baseline is based on the ANCOVA model after adjusting baseline value \& center.
Measured: Baseline and 12 Weeks
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.
A negative score in Change from Baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline
Measured: Baseline and 12 Weeks
Change From Baseline in the MCUI Behavior Therapy Stratified
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.
A negative score in Change from Baseline indicates improvement.
End of Treatment results include patients who had early discontinuation from the study.
Change is calculated as End of Treatment (EOT) - Baseline
Measured: Baseline and 12 Weeks
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms \& impact on sexual quality of life, with a scale of 0 to 12.
Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Measured: Baseline and 12 Weeks
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms \& impact on sexual quality of life, with a scale of 0 to 14.
Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Measured: Baseline and 12 Weeks
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: "Are you satisfied with your treatment?" by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).
Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.
Change is calculated as EOT - Baseline
Measured: Baseline and 12 Weeks
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.
Change from baseline with a lower score indicates an improvement.
End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.
Change is calculated as EOT - Baseline
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573508
- Sponsor's protocol ID
- 905-UC-010
- Acronym
- VIBRANT
- Status last verified
- Sep 2010
- First submitted
- 12 Dec 2007
- Last updated
- 5 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
PubMed 19930331Stoniute 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 37160401Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.
PubMed 21235700
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB
- ClinicalTrials.gov ID
- NCT00573508
- Acronym / sponsor ID
- VIBRANT / 905-UC-010
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 5 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Detailed description
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.
The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.
Primary efficacy will be based on OAB-q symptom bother score.
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 |
|---|---|---|
| Placebo | Active comparator | Drug: PlaceboMatching placebo tablet taken once daily |
| Solifenacin Succinate | Experimental | Drug: Solifenacin Succinate5mg or 10mg tablet taken once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
- History of OAB symptoms for ≥ 3 months
- An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
- Subjects are bothered by symptoms as reflected by PPBC ≥3
Key exclusion criteria (7 listed)
- Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
- Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
- History of diagnosed gastrointestinal obstruction disease
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 |
|---|---|---|
| PlaceboOral Administration | Drug | Placebo |
| Solifenacin SuccinateAlso: VESIcare®, YM905Oral Administration | Drug | Solifenacin Succinate |
Primary outcome
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
Time frame: Baseline and 12 Weeks
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline.
12 secondary outcomes
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Time frame: Baseline, Week 4, Week 8 and Week 12
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Time frame: Baseline, Week 4, Week 8 and Week 12
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
Time frame: Baseline and 12 Weeks
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Time frame: Baseline and 12 Weeks
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Time frame: Baseline, Week 4, Week 8 and Week 12
Change From Baseline in Work Productivity Assessment Index (WPAI)
Time frame: Baseline and 12 Weeks
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
Time frame: Baseline and 12 Weeks
Change From Baseline in the MCUI Behavior Therapy Stratified
Time frame: Baseline and 12 Weeks
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Time frame: Baseline and 12 Weeks
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Time frame: Baseline and 12 Weeks
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
Time frame: Baseline and 12 Weeks
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Time frame: Baseline and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19930331Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
- 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 21235700Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.
- Link to Prescribing InformationLink 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.
Central Contact study director
Astellas Pharma US, Inc.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin Succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 59 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 4 inclusion and 7 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 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score (time frame: Baseline and 12 Weeks). 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 NCT00573508, which also lists 3 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 5 Oct 2010.