Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serenity Pharmaceuticals, Inc.

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