Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Inclusion Criteria:

• Male & female greater or equal to 75 years of age, history of nocturia

Exclusion Criteria:

• CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
• Unexplained pelvic masses
• Urinary bladder surgery or radiotherapy
• Sleep apnea