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

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

• SER120 Nasal Spray 500 ng/day (Drug): SER120 Level 1
• SER120 nasal spray 750 ng/day (Drug): SER120 (750 ng/day)

Primary outcomes

• Serum Sodium Levels at Baseline and During Treatment [baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57]: Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Secondary outcomes

• Change in Mean Nocturic Episodes Per Night [Mean value at Week 8 minus mean value at baseline]: Change in mean nocturic episodes per night between baseline and Week 8
• Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes [8 weeks]: Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline

Sex: All, ages: 75 Years to 95 Years

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

Participant flow

Outcome results

• Serum Sodium Levels at Baseline and During Treatment (Primary), Mean, mmol/L: SER120 500 ng 141.0 +/- 2.4; SER120 750 ng 140.0 +/- 1.7
• Change in Mean Nocturic Episodes Per Night (Secondary), Mean, nocturic episodes per night: SER120 500 ng -1.5 +/- 0.8; SER120 750 ng -1.4 +/- 0.7
• Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes (Secondary), Count of participants, Participants: SER120 500 ng 11; SER120 750 ng 11

Adverse events

Time frame: 8 Weeks

Other adverse events by term