Phase 3
N=810
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT01900704 ↗Enrolled (actual)
810
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment — -1.4; -1.5; -1.2 nocturic episodes per night
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SER120 750 ng (Drug); SER120 1500 ng (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Serenity Pharmaceuticals, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment |
-1.4; -1.5; -1.2 | — |
| PRIMARY Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes |
93; 121; 74 | — |
Summary
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01900704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.