Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

• Phase: 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 episodes per night

Exclusion Criteria:

• CHF

• Diabetis Insipidus

• Renal insufficiency

• Hepatic insufficiency

• Incontinence

• Illnesses 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