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
SER120
DRUGPlacebo
Placebo
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 during the last week of treatment minus the mean number of nocturic episodes at baseline |
| 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. | 145 |
| Placebo All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration with placebo once daily for the remainder of the study. | 149 |
| Total | 294 |
Baseline characteristics
| Characteristic | SER120 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 9.4 | 63.7 years STANDARD_DEVIATION 9.4 | 63.7 years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 42 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 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 | 121 Participants | 236 Participants | 115 Participants |
| Region of Enrollment United States | 145 participants | 294 participants | 149 participants |
| Sex: Female, Male Female | 66 Participants | 128 Participants | 62 Participants |
| Sex: Female, Male Male | 79 Participants | 166 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 105 / 148 | 108 / 153 |
| serious Total, serious adverse events | 2 / 148 | 1 / 153 |
Outcome results
Primary
Change in Mean Number of Nocturic Episodes/Night
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
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 0.9 |
| Placebo | Change in Mean Number of Nocturic Episodes/Night | -1.2 nocturic episodes per night | Standard Deviation 1 |
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 | 58 Participants |
| Placebo | Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | 58 Participants |