Not provided
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In agreement with FDA the study was terminated based on data available.
Not provided
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This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.
Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A 200U | Experimental | Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable). |
|
| botulinum toxin Type A 300U | Experimental | Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable). |
|
| Placebo/botulinum toxin Type A 200U | Other | Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable). |
|
| Placebo/botulinum toxin Type A 300U | Other | Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A injection into the detrusor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement. | Baseline, Week 6 |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement. | Baseline, Week 6 |
| Change From Baseline in FEV1/FVC Ratio | The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Urinary Incontinence Episodes | The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage). | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least a 15% Decrease From Baseline in FVC | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. | Baseline, Weeks 2, 6 and 12 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia | Pennsylvania | United States | ||||
Botulinum toxin Type A 300U was discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) received botulinum toxin Type A 200U instead.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A 200U | Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable). |
| FG001 | Botulinum Toxin Type A 300U | Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable). |
| FG002 | Placebo | Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
|
| |||||||||||||||||||||
| Treatment Cycle 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A 200U | Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable). |
| BG001 | Botulinum Toxin Type A 300U |
| 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 Forced Vital Capacity (FVC) | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement. | Safety Population included all randomized participants who received treatment. | Posted | Mean | Standard Deviation | Liters | Baseline, Week 6 |
|
Not provided
Serious Adverse Events (SAEs) and Adverse Events (AEs) were reported based on the treatment the participant received. SAEs and AEs reported for participants in the Placebo/Botulinum Toxin Type A arm may have occurred while the participant received placebo in Cycle 1 or botulinum toxin Type A in Cycle 2.
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 | Botulinum Toxin Type A 200U | Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
Not provided
| 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 |
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Normal Saline (Placebo) | Drug | Placebo (Normal Saline) injection into the detrusor. |
|
| Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) |
MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure). |
| Baseline, Week 6 |
| Change From Baseline in Maximum Cystometric Capacity (MCC) | MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence). | Baseline, Week 6 |
| Number of Participants With at Least a 20% Decrease From Baseline in FVC |
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. |
| Baseline, Weeks 2, 6 and 12 |
| Herston |
| Queensland |
| Australia |
| Victoria | British Columbia | Canada |
| Chennai | India |
| Withdrawal by Subject |
|
|
| NOT COMPLETED |
|
|
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable). |
| BG002 | Placebo/Botulinum Toxin Type A | Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable). |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable). |
| OG002 | Placebo | Placebo (Normal Saline) injection into the detrusor on Day 1. |
|
|
| Primary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement. | Safety population included all randomized participants who received treatment. | Posted | Mean | Standard Deviation | Liters | Baseline, Week 6 |
|
|
|
| Primary | Change From Baseline in FEV1/FVC Ratio | The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement. | Safety population included all randomized participants who received treatment. | Posted | Mean | Standard Deviation | Ratio | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in the Number of Urinary Incontinence Episodes | The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage). | Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis. | Posted | Mean | Standard Deviation | Episodes | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) | MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure). | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | cm H2O | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence). | Intent-to-treat population included all randomized participants. | Posted | Mean | Standard Deviation | mL | Baseline, Week 6 |
|
|
|
| Other Pre-specified | Number of Participants With at Least a 15% Decrease From Baseline in FVC | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. | Safety population included all randomized participants who received treatment. | Posted | Number | Participants | Baseline, Weeks 2, 6 and 12 |
|
|
|
| Other Pre-specified | Number of Participants With at Least a 20% Decrease From Baseline in FVC | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. | Safety population included all randomized participants who received treatment. | Posted | Number | Participants | Baseline, Weeks 2, 6 and 12 |
|
|
|
| 4 |
| 15 |
| 12 |
| 15 |
| EG001 | Botulinum Toxin Type A 300U | Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable). | 6 | 14 | 12 | 14 |
| EG002 | Placebo/Botulinum Toxin Type A | Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable). | 1 | 12 | 10 | 12 |
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Cellulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Leptospirosis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Renal function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Syringomyelia | Congenital, familial and genetic disorders | MedDRA (15.1) | Systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA (15.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Events not related to treatment. |
|
| Influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Leptospirosis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Viral rhinitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Septic shock | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Staphylococcal infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Vaginal infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Residual urine volume | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Pulmonary function test decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (15.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
| Dysplastic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Carotid artery disease | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Events not related to treatment. |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Events not related to treatment. |
|
| Bladder pain | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Urethral haemorrhage | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment | Event not related to treatment. |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
|
| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.1) | 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.
| 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 |
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=14,12,9) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=14,12,9) |
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