Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 | Drug | Nasal Spray, once a day |
| |
| 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 between baseline and Week 7 | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Urology Associates | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| 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 population
Not provided
| 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 between baseline and Week 7 | Intent-to-treat | Posted | Least Squares Mean | Standard Deviation | nocturic episodes per night | 7 weeks |
|
Not provided
Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
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 | 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 |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Serenity Pharmaceuticals | 8456396760 | 17 | sfein@serenitypharma.com |
Not provided
| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Nasal Spray |
|
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
| 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 | 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 |
|
|
|
| 3 |
| 167 |
| 112 |
| 167 |
| EG001 | Placebo | All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study. | 1 | 159 | 102 | 159 |
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Celulitis | Infections and infestations | Non-systematic Assessment |
|
| diverticulitis | Infections and infestations | Non-systematic Assessment |
|
| ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Headache | 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 |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided