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This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Experimental | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
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| Placebo (Normal saline) | Placebo Comparator | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Drug | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. |
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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 |
|---|---|---|---|
| 24508634 | Background | McVary KT, Roehrborn CG, Chartier-Kastler E, Efros M, Bugarin D, Chen R, Patel A, Haag-Molkenteller C. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2014 Jul;192(1):150-6. doi: 10.1016/j.juro.2014.02.004. Epub 2014 Feb 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
| FG001 | Placebo (Normal Saline) | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Normal saline | Drug | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
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| Baseline, Week 6, Week 24 |
| Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement. | Baseline, Weeks 6, 12 and 24 |
| Duration of Effect | Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points. | 24 Weeks |
| Surrey |
| British Columbia |
| Canada |
| Prague | Czechia |
| Paris | France |
| Munich | Germany |
| Manila | Philippines |
| Poznan | Poland |
| Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
| BG001 | Placebo (Normal Saline) | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
| BG002 | 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 | Count of Participants | 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 Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in the Total International Prostate Symptom Score (IPSS) | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 6, Week 24 |
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| Secondary | Change From Baseline in Peak Urine Flow Rate | Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement. | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure. | Posted | Mean | Standard Deviation | mL/sec | Baseline, Weeks 6, 12 and 24 |
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| Secondary | Duration of Effect | Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points. | Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis. | Posted | Median | 95% Confidence Interval | Weeks | 24 Weeks |
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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 | Botulinum Toxin Type A | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. | 5 | 158 | 42 | 158 | ||
| EG001 | Placebo (Normal Saline) | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. | 8 | 157 | 44 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
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| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
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| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostatic specific antigen increased | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
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| Haematospermia | Reproductive system and breast disorders | MedDRA (15.0) | 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 |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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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 |
| 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 |
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| Male |
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