Treatment of Patients With Nocturia (Non-PK Study)

October 20, 2020 updated by: Serenity Pharmaceuticals, Inc.

A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

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
    • New York
      • New York, New York, United States, 10016
        • University Urology Associates

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Nasal Spray
Experimental: SER120
Drug: SER120
Nasal Spray, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Number of Nocturic Episodes/Night
Time Frame: 7 weeks
Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
7 weeks
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Time Frame: 7 weeks
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
7 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

June 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC-SER120-DB2-200902

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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