Treatment of Patients With Nocturia (Non-PK Study)

A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Inclusion Criteria:

• Male and Female 50 years or older
• Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

• CHF
• Diabetes
• Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency
• Incontinence
• Illness requiring steroids
• Current or past urologic malignancy
• Nephrotic Syndrome
• Unexplained pelvic masses
• Urinary bladder neurological dysfunction
• Urinary bladder surgery or radiotherapy
• Sleep Apnea
• Pregnant or breast feeding