Phase 3
N=750
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT01357356 ↗Enrolled (actual)
750
Serious AEs
2.2%
Results posted
Oct 2020
Primary outcome: Primary: Change in # of Mean Nocturic Episodes Per Night — -1.4; -1.4; -1.6; -1.2 nocturic episodes per night
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SER120 (750 ng/day) (Drug); SER120 (1000 ng/day) (Drug); SER120 (1500 ng/day) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Serenity Pharmaceuticals, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in # of Mean Nocturic Episodes Per Night |
-1.4; -1.4; -1.6; -1.2 | — |
| PRIMARY Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes |
77; 73; 93; 61 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01357356). 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.