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The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onabotulinumtoxinA | Experimental | OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). |
|
| placebo/onabotulinumtoxinA | Other | Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Daily Micturition Episodes | The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement). | Baseline, Week 12 |
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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 |
|---|---|---|---|
| 32665528 | Derived | McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914. | |
| 26231052 |
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| ID | Title | Description |
|---|---|---|
| FG000 | onabotulinumtoxinA | OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). |
| FG001 | Placebo/onabotulinumtoxinA | Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
| |||||||||||||
| Treatment Cycle 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | onabotulinumtoxinA | OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). |
| BG001 | Placebo/onabotulinumtoxinA |
| 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 From Baseline in Number of Daily Episodes of Urinary Incontinence | A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Intent-to-treat population included all randomized patients. | Posted | Mean | Standard Deviation | Incontinence episodes | Baseline, Week 12 |
|
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The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s 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 | onabotulinumtoxinA | OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 14.0. | 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 |
| 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| normal saline | Drug | Normal saline (placebo) injected into the detrusor at Day 1. |
|
| Change From Baseline in Volume Voided Per Micturition | The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement). | Baseline, Week 12 |
| Victoria |
| British Columbia |
| Canada |
| Derived |
| Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5. |
| 24754838 | Derived | Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22. |
| NOT COMPLETED |
|
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). |
|
|
| Secondary | Change From Baseline in Number of Daily Micturition Episodes | The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement). | Intent-to-treat population included all randomized patients. | Posted | Mean | Standard Deviation | micturition episodes | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Volume Voided Per Micturition | The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement). | Intent-to-treat population included all randomized patients. | Posted | Mean | Standard Deviation | milliliters | Baseline, Week 12 |
|
|
|
| 18 |
| 278 |
| 155 |
| 278 |
| EG001 | Placebo/onabotulinumtoxinA | Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). | 16 | 272 | 79 | 272 |
| Myocardial infarction | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Foramen magnum stenosis | Congenital, familial and genetic disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Appendiceal abscess | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 14.0. | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 14.0. | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA version 14.0. | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0. | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0. | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment | Event not treatment related |
|
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.
| 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 |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |