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The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 (desmopressin) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 | Drug | once a day treatment of nocturia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Sodium | Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephen M. Auerbach, MD | Newport Beach | California | 92660 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SER120 750 mcg | All participants received up to 750 mcg SER120 once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | SER120 750 mcg | All participants received up to 750 mcg SER120 once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Serum Sodium | Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline | Safety population | Posted | Mean | Standard Deviation | mmol/L | 40 weeks |
|
|
40 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 | SER120 750 mcg | All participants received up to 750 mcg SER120 once daily | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Serenity Pharmaceuticals | 8456396760 | 17 | sfein@serenitypharma.com |
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| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lack of Efficacy |
|
| Protocol Violation |
|
| administrative |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 376 |
| 30 |
| 376 |
| 305 |
| 376 |
| Cardiovascular disorders | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| pericarditis | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| sick sinus syndrome | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| multiple injuries | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Cervical vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| alcoholism | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| gastric banding | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| medical device removal | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Uvulopalatopharyngoplasty | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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