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The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 500 ng/day | Experimental | SER120 Level 1 (500 ng/day) |
|
| SER120 750 ng/day | Experimental | SER120 Level 2 (750 ng/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 Nasal Spray 500 ng/day | Drug | SER120 Level 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Sodium Levels at Baseline and During Treatment | Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57. | baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Nocturic Episodes Per Night | Change in mean nocturic episodes per night between baseline and Week 8 | Mean value at Week 8 minus mean value at baseline |
| Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Jolene Berg | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SER120 500 ng | All participants received 500 ng once daily |
| FG001 | SER120 750 ng | All participants received 750 ng once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT
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| ID | Title | Description |
|---|---|---|
| BG000 | SER120 500 ng | All participants received 500 ng once daily |
| BG001 | SER120 750 ng | All participants received 750 ng 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 | Serum Sodium Levels at Baseline and During Treatment | Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57. | Safety population | Posted | Mean | Standard Deviation | mmol/L | baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57 |
|
8 Weeks
Safety Population
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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 500 ng | All participants received 500 ng once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | 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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| SER120 nasal spray 750 ng/day |
| Drug |
SER120 (750 ng/day) |
|
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline |
| 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Mean Nocturic Episodes Per Night | Change in mean nocturic episodes per night between baseline and Week 8 | Intent-to-Treat Population | Posted | Mean | Standard Deviation | nocturic episodes per night | Mean value at Week 8 minus mean value at baseline |
|
|
|
| Secondary | Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes | Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline | Intent-To-Treat Polpulation | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | SER120 750 ng | All participants received 750 ng once daily | 0 | 17 | 12 | 17 |
| lacrimation increased | Eye disorders | Non-systematic Assessment |
|
| abnormal sensation in eye | Eye disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| chapped lips | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| gingival pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| hypoaesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| sensation of pressure | General disorders | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| urinary hesitation | Renal and urinary disorders | Non-systematic Assessment |
|
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| rhinalgia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| sinus disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| sebaceous cyst excision | Surgical and medical procedures | Non-systematic Assessment |
|
| skin cosmetic procedure | Surgical and medical procedures | Non-systematic Assessment |
|
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