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The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (normal saline) injected into detrusor on Day 1 |
|
| BOTOX 50 U | Experimental | botulinum toxin Type A 50 U injected into detrusor on Day 1 |
|
| BOTOX 100 U | Experimental | botulinum toxin Type A 100 U injected into detrusor on Day 1 |
|
| BOTOX 150 U | Experimental | botulinum toxin Type A 150 U injected into detrusor on Day 1 |
|
| BOTOX 200 U | Experimental | botulinum toxin Type A 200 U injected into detrusor on Day 1 |
|
| BOTOX 300 U | Experimental | botulinum toxin Type A 300 U injected into detrusor on Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | botulinum toxin Type A injected into detrusor on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Urinary Urge Incontinence Episodes | Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate. | Baseline, Week 2, Week 6, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Micturitions | Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet. | Baseline, Week 2, Week 6, Week 12 |
| Change in Number of Nocturia Episodes |
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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 |
|---|---|---|---|---|---|---|
| Pittsburgh | Pennsylvania | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22464310 | Derived | Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (normal saline)injection on Day 1 into detrusor |
| FG001 | BOTOX 50 U | botulinum toxin Type A 50 U injection on Day 1 into detrusor |
| FG002 | BOTOX 100 U | botulinum toxin Type A 100 U injection on Day 1 into detrusor |
| FG003 | BOTOX 150 U | botulinum toxin Type A 150 U injection on Day 1 into detrusor |
| FG004 | BOTOX 200 U | botulinum toxin Type A 200 U injection on Day 1 into detrusor |
| FG005 | BOTOX 300 U | botulinum toxin Type A 300 U injection on Day 1 into detrusor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (normal saline)injection on Day 1 into detrusor |
| BG001 | BOTOX 50 U | botulinum toxin Type A 50 U injection on Day 1 into detrusor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 in Number of Urinary Urge Incontinence Episodes | Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate. | Intent to Treat | Posted | Number | episodes | Baseline, Week 2, Week 6, Week 12 |
|
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The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
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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 | Placebo (normal saline)injection on Day 1 into detrusor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| 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 |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Placebo | Drug | Placebo (normal saline) injected into detrusor on Day 1 |
|
Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
| Baseline, Week 12 |
| Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters | Baseline, Week 12 |
| Incontinence Quality of Life Instrument (I-QOL) | Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented. | Baseline, Week 2, Week 6, Week 12 |
| Ghent |
| Belgium |
| Victoria | British Columbia | Canada |
| Berlin | Germany |
| Warsaw | Poland |
| Sheffield | United Kingdom |
| BG002 | BOTOX 100 U | botulinum toxin Type A 100 U injection on Day 1 into detrusor |
| BG003 | BOTOX 150 U | botulinum toxin Type A 150 U injection on Day 1 into detrusor |
| BG004 | BOTOX 200 U | botulinum toxin Type A 200 U injection on Day 1 into detrusor |
| BG005 | BOTOX 300 U | botulinum toxin Type A 300 U injection on Day 1 into detrusor |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BOTOX 100 U |
botulinum toxin Type A 100 U injection on Day 1 into detrusor |
| OG003 | BOTOX 150 U | botulinum toxin Type A 150 U injection on Day 1 into detrusor |
| OG004 | BOTOX 200 U | botulinum toxin Type A 200 U injection on Day 1 into detrusor |
| OG005 | BOTOX 300 U | botulinum toxin Type A 300 U injection on Day 1 into detrusor |
|
|
| Secondary | Change in Number of Micturitions | Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet. | Intent to Treat | Posted | Number | micturitions | Baseline, Week 2, Week 6, Week 12 |
|
|
|
| Secondary | Change in Number of Nocturia Episodes | Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. | Intent to Treat | Posted | Number | episodes | Baseline, Week 12 |
|
|
|
| Secondary | Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters | Intent to Treat | Posted | Number | milliliters | Baseline, Week 12 |
|
|
|
| Secondary | Incontinence Quality of Life Instrument (I-QOL) | Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented. | Intent to Treat | Posted | Number | Units on a scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
| Post-Hoc | Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes | Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate. | Intent to Treat | Posted | Number | Percentage of patients | Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 |
|
|
|
| 5 |
| 33 |
| EG001 | BOTOX 50 U | botulinum toxin Type A 50 U injection on Day 1 into detrusor | 9 | 44 |
| EG002 | BOTOX 100 U | botulinum toxin Type A 100 U injection on Day 1 into detrusor | 5 | 44 |
| EG003 | BOTOX 150 U | botulinum toxin Type A 150 U injection on Day 1 into detrusor | 7 | 39 |
| EG004 | BOTOX 200 U | botulinum toxin Type A 200 U injection on Day 1 into detrusor | 4 | 44 |
| EG005 | BOTOX 300 U | botulinum toxin Type A 300 U injection on Day 1 into detrusor | 4 | 46 |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Squamos cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Schizophrenia, undifferentiated type | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Residual urine volume | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| 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 |
| 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 |
| Week 2 |
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| Week 6 |
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| Week 12 |
|
| Week 12 |
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| Week 12 |
|
| Week 2 |
|
| Week 6 |
|
| Week 12 |
|
| Week 6 |
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| Week 12 |
|
| Week 18 |
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| Week 24 |
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| Week 30 |
|
| Week 36 |
|