Nocturia
Conditions
Keywords
decrease in the number of nocturic episodes for patients with nocturia
Brief summary
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
Interventions
DRUGSER120
once a day treatment of nocturia
Sponsors
Serenity Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies * Willing to provide consent for the study
Exclusion criteria
* Incontinence * Diabetes Insipidus, Diabetes Mellitus * CHF * Renal Insufficiency * Significant medical history which make participation unacceptable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum Sodium | 40 weeks | Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SER120 750 mcg All participants received up to 750 mcg SER120 once daily | 376 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | administrative | 9 |
| Overall Study | Adverse Event | 48 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 52 |
Baseline characteristics
| Characteristic | SER120 750 mcg |
|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 376 Participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 376 |
| other Total, other adverse events | 305 / 376 |
| serious Total, serious adverse events | 30 / 376 |
Outcome results
Primary
Mean Serum Sodium
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Time frame: 40 weeks
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SER120 750 mcg | Mean Serum Sodium | Week 4 | -0.3 mmol/L | Standard Deviation 2.2 |
| SER120 750 mcg | Mean Serum Sodium | Week 12 | -0.5 mmol/L | Standard Deviation 2.6 |
| SER120 750 mcg | Mean Serum Sodium | Week 20 | -0.4 mmol/L | Standard Deviation 2.6 |
| SER120 750 mcg | Mean Serum Sodium | Week 28 | -0.8 mmol/L | Standard Deviation 2.4 |
| SER120 750 mcg | Mean Serum Sodium | Week 40 | -0.6 mmol/L | Standard Deviation 2.6 |
| SER120 750 mcg | Mean Serum Sodium | Day 8 | -0.0 mmol/L | Standard Deviation 2.3 |
| SER120 750 mcg | Mean Serum Sodium | Day 15 | -0.4 mmol/L | Standard Deviation 2.3 |
| SER120 750 mcg | Mean Serum Sodium | Day 22 | -0.4 mmol/L | Standard Deviation 2.5 |