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The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 (750 ng/day) | Experimental | SER120 (750 ng/day) |
|
| SER120 (1000 ng/day) | Experimental | SER120 (1000 ng/day) |
|
| SER120 (1500 ng/day) | Experimental | SER120 (1500 ng/day) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 (750 ng/day) | Drug |
| ||
| SER120 (1000 ng/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in # of Mean Nocturic Episodes Per Night | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 | 12 weeks |
| Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Serenity R&D | New City | New York | 10956 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SER120 750 ng | All participants received SER120 750 ng once daily |
| FG001 | SER120 1000 ng | All participants received SER120 1000 ng once daily |
| FG002 | SER120 1500 ng | All participants received SER120 1500 ng once daily |
| FG003 | Placebo | All participants received Placebo once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | SER120 750 ng | All participants received SER120 750 ng once daily |
| BG001 | SER120 1000 ng | All participants received SER120 1000 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 | Change in # of Mean Nocturic Episodes Per Night | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 | Intent to treat population | Posted | Least Squares Mean | Standard Error | nocturic episodes per night | 12 weeks |
|
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Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.
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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 ng | all participants received SER120 750 ng once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Respiratory, thoracic and mediastinal 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 (1000 ng/day) |
|
| SER120 (1500 ng/day) | Drug |
|
| Placebo | Drug |
|
| BG002 | SER120 1500 ng | All participants received SER120 1500 ng once daily |
| BG003 | Placebo | All participants received Placebo once daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
all participants received SER120 1500 ng once daily |
| OG003 | Placebo | all participants received placebo once daily |
|
|
| Primary | Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline | Intent to treat population | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 2 |
| 188 |
| 18 |
| 188 |
| EG001 | SER120 1000 ng | all participants received SER120 1000 ng once daily | 3 | 186 | 15 | 186 |
| EG002 | SER120 1500 ng | all participants received SER120 1500 ng once daily | 5 | 184 | 21 | 184 |
| EG003 | Placebo | all participants received Placebo once daily | 6 | 187 | 19 | 187 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
|
| Tongue neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
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| Joint abscess | Infections and infestations | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Squamous cell carcinoma skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
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