Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

September 14, 2020 updated by: Serenity Pharmaceuticals, Inc.

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

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Phase 2
  • 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 City, New York, United States, 10956
        • Serenity R&D

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 greater than 2 nocturic episode per night

Exclusion Criteria:

  • CHF
  • Diabetis Insipidus
  • Renal Insufficiency
  • Hepatic Insufficiency
  • Incontinence
  • Illness 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: SER120 (750 ng/day)
Drug: SER120 (750 ng/day)
EXPERIMENTAL: SER120 (1000 ng/day)
Drug: SER120 (1000 ng/day)
SER120 (1000 ng/day)
EXPERIMENTAL: SER120 (1500 ng/day)
Drug: SER120 (1500 ng/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in # of Mean Nocturic Episodes Per Night
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 50% or Greater in Reduction of Nocturic Episodes
Time Frame: 12 weeks
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
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

May 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (ESTIMATE)

May 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC-SER120-DB3-201101

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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