Title
Treatment of Patients With Nocturia (Non-PK Study)
A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)
Phase
Phase 3Lead Sponsor
Serenity Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
NocturiaIntervention/Treatment
desmopressin ...Study Participants
326The 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.
Nasal Spray, once a day
Nasal Spray
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
| Event Type | Organ System | Event Term | SER120 | Placebo |
|---|
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
