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

Primary Purpose

Nocturia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SER120 (750 ng/day)

SER120 (1000 ng/day)

SER120 (1500 ng/day)

Placebo

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

50 Years - undefined (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 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

Sites / Locations

Serenity R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SER120 (750 ng/day)

SER120 (1000 ng/day)

SER120 (1500 ng/day)

Placebo

Arm Description

SER120 (750 ng/day)

SER120 (1000 ng/day)

SER120 (1500 ng/day)

Placebo

Outcomes

Primary Outcome Measures

Change in # of Mean Nocturic Episodes Per Night

Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes

Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT01357356

First Posted

May 18, 2011

Last Updated

September 14, 2020

Sponsor

Serenity Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01357356

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Serenity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

750 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SER120 (750 ng/day)

Arm Type

Experimental

Arm Description

SER120 (750 ng/day)

Arm Title

SER120 (1000 ng/day)

Arm Type

Experimental

Arm Description

SER120 (1000 ng/day)

Arm Title

SER120 (1500 ng/day)

Arm Type

Experimental

Arm Description

SER120 (1500 ng/day)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

SER120 (750 ng/day)

Intervention Type

Drug

Intervention Name(s)

SER120 (1000 ng/day)

Intervention Description

SER120 (1000 ng/day)

Intervention Type

Drug

Intervention Name(s)

SER120 (1500 ng/day)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in # of Mean Nocturic Episodes Per Night

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 50% or Greater in Reduction of Nocturic Episodes

Description

Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Serenity R&D

City

New City

State/Province

New York

ZIP/Postal Code

10956

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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