Treatment of Patients With Nocturia (Non-PK Study)

Serenity Pharmaceuticals, Inc.326 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

326

Conditions

Nocturia

Interventions

SER120DRUG

Nasal Spray, once a day

PlaceboDRUG

Nasal Spray

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University Urology Associates

New York, New York, United States

Outcomes

Primary Outcomes

Change in Mean Number of Nocturic Episodes/Night

Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7

Time frame: 7 weeks

Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night

Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline

Time frame: 7 weeks

Data from ClinicalTrials.gov

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