Nocturia
Conditions
Brief summary
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.
Interventions
DRUGSER120
Nasal Spray, once a day
DRUGPlacebo
Nasal Spray
Sponsors
Serenity Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and Female 50 years or older * Nocturia of 6 or more months duration averaging 2 episodes or more per night
Exclusion criteria
* CHF * Diabetes * Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency * Incontinence * Illness requiring steroids * Current or past urologic malignancy * Nephrotic Syndrome * Unexplained pelvic masses * Urinary bladder neurological dysfunction * Urinary bladder surgery or radiotherapy * Sleep Apnea * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Number of Nocturic Episodes/Night | 7 weeks | Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7 |
| Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | 7 weeks | Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 162 |
| 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. | 156 |
| Total | 318 |
Baseline characteristics
| Characteristic | SER120 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 9.1 | 64.6 Years STANDARD_DEVIATION 8.8 | 64.5 Years STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 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 | 152 Participants | 145 Participants | 297 Participants |
| Region of Enrollment United States | 162 participants | 156 participants | 318 participants |
| Sex: Female, Male Female | 55 Participants | 57 Participants | 112 Participants |
| Sex: Female, Male Male | 107 Participants | 99 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 112 / 167 | 102 / 159 |
| serious Total, serious adverse events | 3 / 167 | 1 / 159 |
Outcome results
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
Time frame: 7 weeks
Population: Intent-to-treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SER120 | Change in Mean Number of Nocturic Episodes/Night | -1.3 nocturic episodes per night | Standard Deviation 0.8 |
| Placebo | Change in Mean Number of Nocturic Episodes/Night | -1.2 nocturic episodes per night | Standard Deviation 0.8 |
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
Time frame: 7 weeks
Population: Intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SER120 | Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | 83 Participants |
| Placebo | Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | 64 Participants |