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
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER120 750 ng | Experimental | SER120 750 ng |
|
| SER120 1500 ng | Experimental | SER120 1500 ng |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER120 750 ng | Drug | SER120 750 ng |
| |
| SER120 1500 ng |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 | 12 weeks |
| Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes | Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephen M. Auerbach, MD | Newport Beach | California | 92660 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SER120 1500 ng | All participants received SER120 1500 ng once daily |
| FG001 | SER120 750 ng | All participant received SER120 750 ng once daily |
| FG002 | Placebo | All participants received Placebo once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-To-Treat Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SER120 750 ng | All participants received SER120 750 ng once daily |
| BG001 | SER120 1500 ng | All participants received SER120 1500 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 | Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment | 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 |
|
Not provided
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.
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 750 ng | All participants received SER120 750 ng once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Respiratory, thoracic and mediastinal 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 |
SER120 1500 ng |
|
| Placebo | Drug | Placebo |
|
| BG002 | Placebo | All participants received Placebo once daily |
| BG003 | 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 Placebo once daily |
|
|
| Primary | Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes | Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period | Intent to treat population | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 7 |
| 266 |
| 30 |
| 266 |
| EG001 | SER120 1500 ng | All participants received SER120 1500 ng once daily | 4 | 264 | 30 | 264 |
| EG002 | Placebo | All participants received Placebo once daily | 5 | 267 | 30 | 267 |
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | Non-systematic Assessment |
|
| Gallbladder empyema | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Squamous cell carcinoma skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided