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The study was terminated early due to enrollment challenges.
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The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | botulinum toxin Type A (50U); botulinum toxin Type A (200U) |
|
| 2 | Experimental | botulinum toxin Type A (100U); botulinum toxin Type A (200U) |
|
| 3 | Experimental | botulinum toxin Type A (200U) |
|
| 4 | Other | placebo; botulinum toxin Type A (200U) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline (Placebo); botulinum toxin Type A (200U) | Biological | Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Baseline, Week 6 |
| Change From Baseline in Maximum Detrusor Pressure (MDP) |
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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 |
|---|---|---|---|---|---|---|
| Cairo | Egypt | |||||
Of the 74 patients enrolled into the study, 73 patients received study medication and are included in the analyses. One patient was enrolled but did not receive study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| FG001 | Botulinum Toxin Type A (100U) | botulinum toxin Type A (100U) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
|
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|
| botulinum toxin Type A (50U); botulinum toxin Type A (200U) | Biological | botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor |
|
|
| botulinum toxin Type A (100U); botulinum toxin Type A (200U) | Biological | botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor |
|
|
| botulinum toxin Type A (200U) | Biological | botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor |
|
|
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. |
| Baseline, Week 6 |
| Thessaloniki |
| Greece |
| Ahmadābād | India |
| Beirut | Lebanon |
| Belgrade | Serbia |
| Ankara | Turkey (Türkiye) |
| FG002 | Botulinum Toxin Type A (50U) | botulinum toxin Type A (50U) |
| FG003 | Placebo | Normal saline (placebo) |
| COMPLETED |
|
| NOT COMPLETED |
|
| Treatment Cycle 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) |
| BG001 | Botulinum Toxin Type A (100U) | botulinum toxin Type A (100U) |
| BG002 | Botulinum Toxin Type A (50U) | botulinum toxin Type A (50U) |
| BG003 | Placebo | Normal saline (placebo) |
| BG004 | 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, Customized | Number | participants |
| ||||||||||||||||
| 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 | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment | Posted | Mean | Standard Deviation | Number of Weekly Episodes | Baseline, Week 6 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment | Posted | Mean | Standard Deviation | Milliliters (mL) of urine | Baseline, Week 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Maximum Detrusor Pressure (MDP) | Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. | Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment | Posted | Mean | Standard Deviation | Centimeters of water (cm H2O) | Baseline, Week 6 |
|
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND 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 | Botulinum Toxin Type A (200U) | botulinum toxin Type A (200U) | 2 | 17 | 11 | 17 | ||
| EG001 | Botulinum Toxin Type A (100U) | botulinum toxin Type A (100U) | 2 | 21 | 17 | 21 | ||
| EG002 | Botulinum Toxin Type A (50U) | botulinum toxin Type A (50U) | 2 | 19 | 11 | 19 | ||
| EG003 | Placebo | Normal saline (placebo) | 6 | 16 | 13 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (13.0) | Non-systematic Assessment | Both events not related to study medication. |
|
| Malaria | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intestinal stoma | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (13.0) | Non-systematic Assessment | Both events not related to study drug |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intestinal stoma | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
Due to recruitment difficulties, study enrollment was stopped early.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@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 |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 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 |
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| Between 40 and 64 years |
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| Between 65 and 74 years |
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| >= 75 years |
|
| Male |
|
| Week 6 |
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| Units | Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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