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This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Experimental | OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). |
|
| Placebo/OnabotulinumtoxinA | Other | Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | OnabotulinumtoxinA (BOTOX®) injected into the detrusor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes | Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes. | Baseline, Week 12 |
| Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence | Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening. |
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Inclusion Criteria:
-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamer Aboushwareb | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologic Clinics of North Alabama | Huntsville | Alabama | 35801 | United States | ||
| Alaska Urological Institute dba Alaska Clinical Research Center |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA | OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). |
| FG001 | Placebo/OnabotulinumtoxinA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 |
|
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| Normal saline | Drug | Normal saline (placebo) injected into the detrusor. |
|
| Baseline, Week 12 |
| Change From Baseline in the Daily Average Number of Micturition Episodes | The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Baseline, Week 12 |
| Change From Baseline in the Daily Average Number of Urgency Episodes | The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Baseline, Week 12 |
| Change From Baseline in the Daily Average Number of Nocturia Episodes | Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. 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. | Baseline, Week 12 |
| Anchorage |
| Alaska |
| 99503 |
| United States |
| South Orange County Medical Research Center | Laguna Hills | California | 92653 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Genesis Research LLC | San Diego | California | 92123 | United States |
| U. Colorado, School of Med. | Aurora | Colorado | 80045 | United States |
| Genitourinary Surgical Consultants | Denver | Colorado | 80220 | United States |
| Urology Associates of Norwalk | Norwalk | Connecticut | 06850 | United States |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | United States |
| Bladder and Prostate Health Investigations, LLC | Miramar | Florida | 33029 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Urology Health Team, PLLC | Ocala | Florida | 34474 | United States |
| Southeastern Research Group, Inc. | Tallahassee | Florida | 32308 | United States |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | United States |
| Northeast Indiana | Fort Wayne | Indiana | 46825 | United States |
| Urogynecology Associates | Indianapolis | Indiana | 46202 | United States |
| Deaconess Clinic, Inc. | Newburgh | Indiana | 47630 | United States |
| Urology of Indiana, LLC | Noblesville | Indiana | 46062 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Owings Mills | Maryland | 21117 | United States |
| Brooklyn Urology Research Group | Brooklyn | New York | 11215 | United States |
| Accumed Research | Garden City | New York | 11530 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Premier Medical Group of the Hudson Valley | Newburgh | New York | 12550 | United States |
| Advanced Urology Centers of NY A division of IMP | Plainview | New York | 11803 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| Associated Medical Professionals of New York, PLLC | Syracuse | New York | 13210 | United States |
| Carolina Urology Partners, PLLC | Gastonia | North Carolina | 28054 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| TriState Urologic Services PSC Inc., dba The Urology Group | Cincinnati | Ohio | 45212 | United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Institute of Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18103 | United States |
| Urologic Consultants of Southern Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group | State College | Pennsylvania | 16801 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | United States |
| Integrity Medical Research, LLC | Mountlake Terrace | Washington | 98043 | United States |
| The Polyclinic | Seattle | Washington | 98104 | United States |
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cycle 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA | OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). |
| BG001 | Placebo/OnabotulinumtoxinA | Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). |
| 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 |
|
| 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 | Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes | Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes. | Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12. | Posted | Number | percentage of participants | Baseline, Week 12 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence | Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12. | Posted | Mean | Standard Deviation | incontinence episodes | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening. | Intent-to-Treat Population included all participants who were randomized to study drug, "n" is the number of participants with available data at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Average Number of Micturition Episodes | The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12. | Posted | Mean | Standard Deviation | micturition episodes | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Average Number of Urgency Episodes | The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening. | Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12. | Posted | Mean | Standard Deviation | urgency episodes | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Average Number of Nocturia Episodes | Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. 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. | Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12. | Posted | Mean | Standard Deviation | nocturia episodes | Baseline, Week 12 |
|
|
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The Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for 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 | OnabotulinumtoxinA (Cycle 1) | OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 1. | 6 | 128 | 51 | 128 | ||
| EG001 | Placebo (Cycle 1) | Placebo (Normal saline) injected into the detrusor on Day 1 of Cycle 1. | 8 | 125 | 34 | 125 | ||
| EG002 | OnabotulinumtoxinA (Cycle 2) | OnabotulinumtoxinA (BOTOX®) 100 U injected into the detrusor at Day 1 in Cycle 2. | 3 | 195 | 75 | 195 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Residual urine volume increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bladder discomfort | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary straining | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc | 1-877-277-8566 | IR-CTRegistration@allergan.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 |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
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| Male |
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
| Participants |
|
|