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

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SER120 750 ng
SER120 1500 ng
Placebo
Sponsored by
Serenity Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stephen M. Auerbach, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SER120 750 ng

SER120 1500 ng

Placebo

Arm Description

SER120 750 ng

SER120 1500 ng

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 12, 2013
Last Updated
November 6, 2020
Sponsor
Serenity Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01900704
Brief Title
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Acronym
DB4
Official Title
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serenity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
810 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SER120 750 ng
Arm Type
Experimental
Arm Description
SER120 750 ng
Arm Title
SER120 1500 ng
Arm Type
Experimental
Arm Description
SER120 1500 ng
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SER120 750 ng
Intervention Description
SER120 750 ng
Intervention Type
Drug
Intervention Name(s)
SER120 1500 ng
Intervention Description
SER120 1500 ng
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
Description
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Time Frame
12 weeks
Title
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
Description
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stephen M. Auerbach, MD
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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