Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® 100 U/BOTOX® 100 U | Active Comparator | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable. |
|
| Placebo/BOTOX® 100 U | Placebo Comparator | Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | OnabotulinumtoxinA (BOTOX®) injection into the bladder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Complete Continence | Complete continence is defined as 100% reduction in urinary incontinence from Baseline. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12] |
| Change From Baseline in Daily Average Number of Micturition Episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dana Fetterolf | Allergan | Study Director |
| Amin Boroujerdi | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Urology Associates | Laguna Hills | California | 92653 | United States | ||
| Tower Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33955921 | Derived | Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available. |
| Label | URL |
|---|---|
| More Information | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® 100 U/BOTOX® 100 U | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period. |
| FG001 | Placebo/BOTOX® 100 U |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2019 | Dec 9, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (saline) | Drug | Placebo (saline) injection into the bladder. |
|
The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses. |
| Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
| Change From Baseline in Daily Average Number of Urgency Episodes | The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
| Change From Baseline in Daily Average Number of Nocturia Episodes | The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses. | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12 |
| Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS) | The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved. | Week 12 |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| Genitourinary Surgical Consultants | Denver | Colorado | 80220 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| PMG Research of Christie Clinic | Champaign | Illinois | 81820 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47113 | United States |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Urogynecology Associates | Indianapolis | Indiana | 46062 | United States |
| Urology of Indiana | Noblesville | Indiana | 46062 | United States |
| Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology | Owings Mills | Maryland | 21117 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Michigan Institute of Urology, P.C. | Troy | Michigan | 48084 | United States |
| Adult and Pediatric Urology | Omaha | Nebraska | 68114 | United States |
| Premier Urology LLC | Edison | New Jersey | 08837 | United States |
| Western New York Urology Associates | Cheektowaga | New York | 14225 | United States |
| Manhattan Medical Research | New York | New York | 10016 | 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 |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| Sandhills Medical Center | Hamlet | North Carolina | 28345 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Virginia Urology | Richmond | Virginia | 23230 | United States |
| Virginia Urology Center | Richmond | Virginia | 23235 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| Integrity Medical Research, LLC | Mountlake Terrace | Washington | 98043 | United States |
Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period. |
| mITT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Re-Treatment Period |
|
Intent-to-treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® 100 U/BOTOX® 100 U | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period. |
| BG001 | Placebo/BOTOX® 100 U | Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period and a second injection BOTOX® 100 U after Week 12 if applicable in the Open-Label Re-Treatment Period. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Daily Average Number of Urinary Incontinence Episodes | The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. | Modified Intent-to-treat (mITT) Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. | Mean | Standard Deviation | incontinence episodes per day |
|
| 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 Daily Average Number of Urinary Incontinence Episodes | The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses. | Modified Intent-to-treat (mITT) Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. | Posted | Least Squares Mean | Standard Error | incontinence episodes per day | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Complete Continence | Complete continence is defined as 100% reduction in urinary incontinence from Baseline. | mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint. | Posted | Number | percentage of participants | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12] |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Average Number of Micturition Episodes | The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses. | mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Least Squares Mean | Standard Error | micturition episodes per day | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Average Number of Urgency Episodes | The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses. | mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Least Squares Mean | Standard Error | urgency episodes per day | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Average Number of Nocturia Episodes | The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses. | mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint. | Posted | Least Squares Mean | Standard Error | nocturia episodes per day | Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS) | The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved. | mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint. | Posted | Number | percentage of participants | Week 12 |
|
|
Randomization to the Study Exit Visit (Up to 70 Weeks)
ITT population, all randomized participants, was used to determine the number at risk for All-Cause Mortality. Safety Population, all participants who received study drug, was used to determine the number of participants at risk for Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind: BOTOX® 100 U | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 in the Double-Blind Treatment Period. | 0 | 80 | 5 | 78 | 31 | 78 |
| EG001 | Double Blind: Placebo | Placebo (saline) injection into the bladder on Day 1 in the Double-Blind Treatment Period. | 0 | 40 | 2 | 39 | 13 | 39 |
| EG002 | Open Label: BOTOX® 100 U/BOTOX® 100 U | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder in the Open-Label Re-Treatment Period in participants who previously received BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1. | 0 | 58 | 2 | 58 | 14 | 58 |
| EG003 | Open Label: Placebo/BOTOX® 100 U | BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder in the Open-Label Re-Treatment Period in participants who previously received Placebo (saline) injection into the bladder on Day 1. | 0 | 33 | 1 | 33 | 16 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA: 19.0 | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA: 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA: 19.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA: 19.0 | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 19.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA: 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA: 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA: 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA: 19.0 | 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 | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Dec 9, 2019 | Prot_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|