Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4 (DB4)

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

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

810

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
    • California
      • Newport Beach, California, United States, 92660
        • Stephen M. Auerbach, MD

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 to 95 years (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 greater than 2 nocturic episodes per night

Exclusion Criteria:

  • CHF
  • Diabetis Insipidus
  • Renal insufficiency
  • Hepatic insufficiency
  • Incontinence
  • Illnesses requiring systemic steroids
  • Malignancy within the past 5 years
  • Sleep apnea
  • Nephrotic syndrome
  • Unexplained pelvic mass
  • Urinary bladder neurological dysfunction
  • Urinary bladder surgery or radiotherapy
  • 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: SER120 750 ng
Drug: SER120 750 ng
SER120 750 ng
Experimental: SER120 1500 ng
Drug: SER120 1500 ng
SER120 1500 ng

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
Time Frame: 12 weeks
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
12 weeks
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
Time Frame: 12 weeks
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
12 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

August 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC-SER120-DB4-201301

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.

Clinical Trials on Nocturia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe