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Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Active Comparator | Matching placebo tablet taken once daily |
|
| Solifenacin Succinate | Experimental | 5mg or 10mg tablet taken once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral Administration |
| |
| Solifenacin Succinate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36067 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19930331 | Result | 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. | |
| 37160401 |
| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo tablet taken once daily |
| FG001 | Solifenacin Succinate | 5mg or 10mg tablet taken once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Oral Administration |
|
|
| 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. | 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 | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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 | 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 | Baseline and 12 Weeks |
| Phoenix |
| Arizona |
| 85051 |
| United States |
| Tucson | Arizona | 85741 | United States |
| Buena Park | California | 90620 | United States |
| Carmichael | California | 95608 | United States |
| Fresno | California | 93720 | United States |
| Sacramento | California | 95825 | United States |
| San Bernardino | California | 92404 | United States |
| San Diego | California | 92108 | United States |
| Aurora | Colorado | 80012 | United States |
| Denver | Colorado | 80211 | United States |
| Denver | Colorado | 80220 | United States |
| Englewood | Colorado | 32308 | United States |
| Waterbury | Connecticut | 67080 | United States |
| Clearwater | Florida | 33761 | United States |
| Plantation | Florida | 33324 | United States |
| Tallahassee | Florida | 32308 | United States |
| Tampa | Florida | 33607 | United States |
| Tampa | Florida | 33613 | United States |
| Wellington | Florida | 33414 | United States |
| Roswell | Georgia | 30076 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Melrose Park | Illinois | 60160 | United States |
| Jeffersonville | Indiana | 47130 | United States |
| Shreveport | Louisiana | 71106 | United States |
| Watertown | Massachusetts | 02472 | United States |
| Billings | Montana | 59102 | United States |
| Omaha | Nebraska | 68114 | United States |
| Englewood | New Jersey | 07631 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Endwell | New York | 13760 | United States |
| Garden City | New York | 11530 | United States |
| Kingston | New York | 12401 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| Orchard Park | New York | 14127 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Concord | North Carolina | 28025 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58104 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Edmond | Oklahoma | 73034 | United States |
| Central Point | Oregon | 97502 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Greer | South Carolina | 29650 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Arlington | Texas | 76017 | United States |
| Austin | Texas | 78759 | United States |
| Bedford | Texas | 76021 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Houston | Texas | 77024 | United States |
| Mount Lake | Washington | 98043 | United States |
| Spokane | Washington | 99202 | United States |
| Tacoma | Washington | 98405 | United States |
| Madison | Wisconsin | 53703 | United States |
| 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. |
| 21235700 | Derived | Crosby 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. |
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo tablet taken once daily |
| BG001 | Solifenacin Succinate | 5mg or 10mg tablet taken once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants per arm is consistent for all categories / rows of the data table. | Posted | Mean | Standard Deviation | OAB-q Score | Baseline and 12 Weeks |
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| Secondary | 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. | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | Posted | Mean | Standard Deviation | OAB-q Score | Baseline, Week 4, Week 8 and Week 12 |
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| Secondary | 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. | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | Posted | Mean | Standard Deviation | OAB-q HRQL Total Score | Baseline, Week 4, Week 8 and Week 12 |
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| Secondary | 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 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. | Posted | Number | Participants | Baseline and 12 Weeks |
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| Secondary | 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. | The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal). A few patients who completed the BSW Questionnaire did not adequately complete the " Benefits" Section and therefore are considered 'N/A' for that Section. | Posted | Number | Participants | Baseline and 12 Weeks |
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| Secondary | 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. | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles. | Posted | Mean | Standard Deviation | OAB-q HRQL Sub Domain Score | Baseline, Week 4, Week 8 and Week 12 |
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| Secondary | 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. | Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles. | Posted | Mean | Standard Deviation | Percentage of indicated parameter | Baseline and 12 Weeks |
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| Secondary | 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 | Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles. | Posted | Mean | Standard Deviation | Number of categorical items | Baseline and 12 Weeks |
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| Secondary | 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 | Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles. | Posted | Mean | Standard Deviation | Number of Days | Baseline and 12 Weeks |
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| Secondary | 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. | Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | Posted | Mean | Standard Deviation | ICIQ-MLUTSsex | Baseline and 12 Weeks |
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| Secondary | 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. | Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | Posted | Mean | Standard Deviation | ICIQ-FLUTSsex | Baseline and 12 Weeks |
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| Secondary | 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 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles. | Posted | Mean | Standard Deviation | TS-VAS | Baseline and 12 Weeks |
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| Secondary | 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 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles. | Posted | Mean | Standard Deviation | Number of Category Events / 24 Hours | Baseline and 12 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo tablet taken once daily | 6 | 382 | 18 | 382 | ||
| EG001 | Solifenacin Succinate | 5mg or 10mg tablet taken once daily | 3 | 386 | 84 | 386 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Migration of Implant | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Ammonia Increased | Investigations | MedDRA (7.0) | Systematic Assessment |
| |
| Hypokalaemia | Investigations | MedDRA (7.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Intervertebral Discitis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Ruptured Cerebral Aneurysm | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Astellas Medical Monitor | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
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