Overview

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