Long Term Safety Assessment of SER120 in Patients With Nocturia

Phase 3CompletedNCT00981682

Serenity Pharmaceuticals, Inc.376 enrolled

Overview

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

376

Conditions

Nocturia

Interventions

SER120DRUG

once a day treatment of nocturia

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies * Willing to provide consent for the study Exclusion Criteria: * Incontinence * Diabetes Insipidus, Diabetes Mellitus * CHF * Renal Insufficiency * Significant medical history which make participation unacceptable

Locations (1)

Stephen M. Auerbach, MD

Newport Beach, California, United States

Outcomes

Primary Outcomes

Mean Serum Sodium

Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline

Time frame: 40 weeks

Data from ClinicalTrials.gov

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