Nocturia
Conditions
Brief summary
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Detailed description
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
Interventions
DRUGSER120 Nasal Spray 500 ng/day
SER120 Level 1
DRUGSER120 nasal spray 750 ng/day
SER120 (750 ng/day)
Sponsors
Serenity Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Male & female greater or equal to 75 years of age, history of nocturia
Exclusion criteria
* CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome * Unexplained pelvic masses * Urinary bladder surgery or radiotherapy * Sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Sodium Levels at Baseline and During Treatment | baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57 | Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Nocturic Episodes Per Night | Mean value at Week 8 minus mean value at baseline | Change in mean nocturic episodes per night between baseline and Week 8 |
| Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes | 8 weeks | Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SER120 500 ng All participants received 500 ng once daily | 15 |
| SER120 750 ng All participants received 750 ng once daily | 16 |
| Total | 31 |
Baseline characteristics
| Characteristic | SER120 500 ng | Total | SER120 750 ng |
|---|---|---|---|
| Age, Continuous | 79 years STANDARD_DEVIATION 3.6 | 79.1 years STANDARD_DEVIATION 3.4 | 79.1 years STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Region of Enrollment United States | 15 Participants | 31 Participants | 16 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 15 | 12 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
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.
Time frame: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Baseline | 141.0 mmol/L | Standard Deviation 2.4 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 22 | 139.5 mmol/L | Standard Deviation 3.2 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 8 | 139.1 mmol/L | Standard Deviation 3.2 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 29 | 139.7 mmol/L | Standard Deviation 2.7 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 4 | 139.2 mmol/L | Standard Deviation 3 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 43 | 139.9 mmol/L | Standard Deviation 2.7 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 15 | 140.4 mmol/L | Standard Deviation 2.1 |
| SER120 500 ng | Serum Sodium Levels at Baseline and During Treatment | Day 57 | 140.9 mmol/L | Standard Deviation 2.6 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 57 | 141.1 mmol/L | Standard Deviation 1.7 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Baseline | 140.0 mmol/L | Standard Deviation 1.7 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 4 | 140.3 mmol/L | Standard Deviation 1.3 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 8 | 140.4 mmol/L | Standard Deviation 1.8 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 15 | 140.2 mmol/L | Standard Deviation 1.4 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 22 | 140.0 mmol/L | Standard Deviation 1.4 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 29 | 139.7 mmol/L | Standard Deviation 2.1 |
| SER120 750 ng | Serum Sodium Levels at Baseline and During Treatment | Day 43 | 139.6 mmol/L | Standard Deviation 1.5 |
Secondary
Change in Mean Nocturic Episodes Per Night
Change in mean nocturic episodes per night between baseline and Week 8
Time frame: Mean value at Week 8 minus mean value at baseline
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SER120 500 ng | Change in Mean Nocturic Episodes Per Night | -1.5 nocturic episodes per night | Standard Deviation 0.8 |
| SER120 750 ng | Change in Mean Nocturic Episodes Per Night | -1.4 nocturic episodes per night | Standard Deviation 0.7 |
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
Time frame: 8 weeks
Population: Intent-To-Treat Polpulation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SER120 500 ng | Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes | 11 Participants |
| SER120 750 ng | Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes | 11 Participants |