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A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Experimental | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. |
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| solifenacin | Active Comparator | Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
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| placebo | Placebo Comparator | Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX® | Biological | BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Study Baseline, Week 12 |
| Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes. | Study Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 | A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.' | Week 12 |
| Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28161352 | Background | Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naive Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. J Urol. 2017 Jul;198(1):167-175. doi: 10.1016/j.juro.2017.01.069. Epub 2017 Feb 1. | |
| 37160401 |
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Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. |
| FG001 | Solifenacin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| solifenacin | Drug | Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks. |
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| Botox placebo (normal saline) | Drug | Botox placebo (normal saline) intradetrusor injection at Day 1. |
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| solifenacin placebo | Drug | Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks. |
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The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Study Baseline, Week 12 |
| Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 | Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Study Baseline, Week 12 |
| Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Study Baseline, Week 12 |
| Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Study Baseline, Week 12 |
| Leuven |
| Belgium |
| Vancouver | British Columbia | Canada |
| Toronto | Ontario | Canada |
| Prague | Czechia |
| Berlin | Germany |
| Warsaw | Poland |
| London | United Kingdom |
| Derived |
| 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. |
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| FG002 | Placebo | Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. |
| BG001 | Solifenacin | Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| BG002 | Placebo | Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Mean | Standard Deviation | Incontinence Episodes | Study Baseline, Week 12 |
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| Primary | Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Number | Percentage of Patients | Study Baseline, Week 12 |
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| Secondary | Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 | A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.' | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Number | 95% Confidence Interval | Percentage of Patients | Week 12 |
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| Secondary | Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 | The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Mean | Standard Deviation | Micturition Episodes | Study Baseline, Week 12 |
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| Secondary | Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 | Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Mean | Standard Deviation | Nocturia Episodes | Study Baseline, Week 12 |
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| Secondary | Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Mean | Standard Deviation | Scores on a Scale | Study Baseline, Week 12 |
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| Secondary | Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: includes all patients according to the group to which they are randomized | Posted | Mean | Standard Deviation | Scores on a Scale | Study Baseline, Week 12 |
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The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
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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 | BOTOX® | Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection. | 6 | 145 | 57 | 145 | ||
| EG001 | Solifenacin | Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. | 6 | 147 | 40 | 147 | ||
| EG002 | Placebo | Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection. | 2 | 60 | 13 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Polysubstance dependence | Psychiatric disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA Version 18.0 | Systematic Assessment | FEMALE ONLY |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 18.0 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA Version 18.0 | Systematic Assessment |
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| Residual urine volume | Investigations | MedDRA Version 18.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA Version 18.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| 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 |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000069464 | Solifenacin Succinate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| ≥65 years |
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| Male |
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Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
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Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
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