Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
Phase 2
Completed
- Conditions
- Nocturia
- Interventions
- Drug: SER120 (1000 ng/day)Drug: SER120 (750 ng/day)Drug: SER120 (1500 ng/day)Drug: Placebo
- Registration Number
- NCT01357356
- Lead Sponsor
- Serenity Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SER120 (1000 ng/day) SER120 (1000 ng/day) SER120 (1000 ng/day) SER120 (750 ng/day) SER120 (750 ng/day) SER120 (750 ng/day) SER120 (1500 ng/day) SER120 (1500 ng/day) SER120 (1500 ng/day) Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change in # of Mean Nocturic Episodes Per Night 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 12 weeks Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Serenity R&D
🇺🇸New City, New York, United States