Nocturia
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
Interventions
DRUGSER120 (750 ng/day)
DRUGSER120 (1000 ng/day)
SER120 (1000 ng/day)
DRUGSER120 (1500 ng/day)
DRUGPlacebo
Sponsors
Serenity Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 greater than 2 nocturic episode per night
Exclusion criteria
* CHF * Diabetis Insipidus * Renal Insufficiency * Hepatic Insufficiency * Incontinence * Illness requiring systemic steroids * Malignancy within the past 5 years * Sleep Apnea * Nephrotic Syndrome * Unexplained Pelvic Mass * Urinary Bladder Neurological dysfunction * Urinary Bladder Surgery or Radiotherapy * Pregnant or Breast Feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in # of Mean Nocturic Episodes Per Night | 12 weeks | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 |
| Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | 12 weeks | Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SER120 750 ng All participants received SER120 750 ng once daily | 186 |
| SER120 1000 ng All participants received SER120 1000 ng once daily | 183 |
| SER120 1500 ng All participants received SER120 1500 ng once daily | 179 |
| Placebo All participants received Placebo once daily | 186 |
| Total | 734 |
Baseline characteristics
| Characteristic | Total | SER120 750 ng | SER120 1000 ng | SER120 1500 ng | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 9.3 | 66.3 years STANDARD_DEVIATION 9.1 | 66.1 years STANDARD_DEVIATION 8.9 | 66.0 years STANDARD_DEVIATION 9.4 | 66.0 years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 4 Participants | 2 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 15 Participants | 18 Participants | 20 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 635 Participants | 165 Participants | 163 Participants | 152 Participants | 155 Participants |
| Region of Enrollment Canada | 57 participants | 15 participants | 12 participants | 19 participants | 11 participants |
| Region of Enrollment United States | 677 participants | 171 participants | 171 participants | 160 participants | 175 participants |
| Sex: Female, Male Female | 302 Participants | 79 Participants | 74 Participants | 75 Participants | 74 Participants |
| Sex: Female, Male Male | 432 Participants | 107 Participants | 109 Participants | 104 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 188 | 15 / 186 | 21 / 184 | 19 / 187 |
| serious Total, serious adverse events | 2 / 188 | 3 / 186 | 5 / 184 | 6 / 187 |
Outcome results
Primary
Change in # of Mean Nocturic Episodes Per Night
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Time frame: 12 weeks
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SER120 750 ng | Change in # of Mean Nocturic Episodes Per Night | -1.4 nocturic episodes per night | Standard Error 0.07 |
| SER120 1000 ng | Change in # of Mean Nocturic Episodes Per Night | -1.4 nocturic episodes per night | Standard Error 0.07 |
| SER120 1500 ng | Change in # of Mean Nocturic Episodes Per Night | -1.6 nocturic episodes per night | Standard Error 0.07 |
| Placebo | Change in # of Mean Nocturic Episodes Per Night | -1.2 nocturic episodes per night | Standard Error 0.07 |
Primary
Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
Time frame: 12 weeks
Population: Intent to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SER120 750 ng | Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | 77 Participants |
| SER120 1000 ng | Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | 73 Participants |
| SER120 1500 ng | Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | 93 Participants |
| Placebo | Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | 61 Participants |