A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
Overview
- Phase
- Phase 2
- Intervention
- SER120 (750 ng/day)
- Conditions
- Nocturia
- Sponsor
- Serenity Pharmaceuticals, Inc.
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- Change in # of Mean Nocturic Episodes Per Night
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
- •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
Arms & Interventions
SER120 (750 ng/day)
SER120 (750 ng/day)
Intervention: SER120 (750 ng/day)
SER120 (1000 ng/day)
SER120 (1000 ng/day)
Intervention: SER120 (1000 ng/day)
SER120 (1500 ng/day)
SER120 (1500 ng/day)
Intervention: SER120 (1500 ng/day)
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in # of Mean Nocturic Episodes Per Night
Time Frame: 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
Time Frame: 12 weeks
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline