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The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 | Experimental | SER120 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 | Drug | SER120 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Number of Nocturic Episodes/Night | Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline | 7 weeks |
| Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Medical Research Assoc. | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SER120 | All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. |
| FG001 | Placebo | All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | SER120 | All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. |
| BG001 | Placebo |
| 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 Mean Number of Nocturic Episodes/Night | Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline | Intent-to-treat | Posted | Least Squares Mean | Standard Deviation | nocturic episodes per night | 7 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 | All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal 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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| Drug |
Placebo |
|
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline | Intent-to-treat | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| 2 |
| 148 |
| 105 |
| 148 |
| EG001 | Placebo | All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study. | 1 | 153 | 108 | 153 |
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system 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 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Post nasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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