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

Serenity Pharmaceuticals, Inc.32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nocturia

Interventions

SER120 Nasal Spray 500 ng/dayDRUG

SER120 Level 1

SER120 nasal spray 750 ng/dayDRUG

SER120 (750 ng/day)

Eligibility

Sex: ALLMin age: 75 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Jolene Berg

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Serum Sodium Levels at Baseline and During Treatment

Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Time frame: 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

Change in mean nocturic episodes per night between baseline and Week 8

Time frame: Mean value at Week 8 minus mean value at baseline

Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes

Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.