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

November 6, 2020 updated by: Serenity Pharmaceuticals, Inc.

A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dr. Jolene Berg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SER120 500 ng/day
SER120 Level 1 (500 ng/day)
Drug: SER120 Nasal Spray 500 ng/day
SER120 Level 1
Experimental: SER120 750 ng/day
SER120 Level 2 (750 ng/day)
Drug: SER120 nasal spray 750 ng/day
SER120 (750 ng/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Sodium Levels at Baseline and During Treatment
Time Frame: 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.
baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Nocturic Episodes Per Night
Time Frame: Mean value at Week 8 minus mean value at baseline
Change in mean nocturic episodes per night between baseline and Week 8
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
Time Frame: 8 weeks
Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serenity Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC-SER120-ELD-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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