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Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900704
Acronym
DB4
Enrollment
810
Registered
2013-07-16
Start date
2013-08-31
Completion date
2015-04-30
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia

Brief summary

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Interventions

DRUGSER120 750 ng

SER120 750 ng

DRUGSER120 1500 ng

SER120 1500 ng

DRUGPlacebo

Placebo

Sponsors

Serenity Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Male and female 50 years or older * Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night

Exclusion criteria

* CHF * Diabetis Insipidus * Renal insufficiency * Hepatic insufficiency * Incontinence * Illnesses 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

MeasureTime frameDescription
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment12 weeksChange was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes12 weeksPercent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

Countries

United States

Participant flow

Participants by arm

ArmCount
SER120 750 ng
All participants received SER120 750 ng once daily
262
SER120 1500 ng
All participants received SER120 1500 ng once daily
260
Placebo
All participants received Placebo once daily
260
Total782

Baseline characteristics

CharacteristicSER120 750 ngSER120 1500 ngPlaceboTotal
Age, Continuous66.5 years
STANDARD_DEVIATION 8.8
66.1 years
STANDARD_DEVIATION 9.2
65.8 years
STANDARD_DEVIATION 9
66.1 years
STANDARD_DEVIATION 9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants6 Participants1 Participants11 Participants
Race (NIH/OMB)
Black or African American
26 Participants40 Participants39 Participants105 Participants
Race (NIH/OMB)
More than one race
3 Participants2 Participants0 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
229 Participants212 Participants220 Participants661 Participants
Region of Enrollment
Canada
15 participants22 participants11 participants48 participants
Region of Enrollment
United States
247 participants238 participants249 participants734 participants
Sex: Female, Male
Female
117 Participants113 Participants114 Participants344 Participants
Sex: Female, Male
Male
145 Participants147 Participants146 Participants438 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
30 / 26630 / 26430 / 267
serious
Total, serious adverse events
7 / 2664 / 2645 / 267

Outcome results

Primary

Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
SER120 750 ngNumber of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment-1.4 nocturic episodes per nightStandard Error 0.06
SER120 1500 ngNumber of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment-1.5 nocturic episodes per nightStandard Error 0.06
PlaceboNumber of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment-1.2 nocturic episodes per nightStandard Error 0.06
Primary

Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes

Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

Time frame: 12 weeks

Population: Intent to treat population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SER120 750 ngPercent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes93 Participants
SER120 1500 ngPercent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes121 Participants
PlaceboPercent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes74 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026