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Treatment of Patients With Nocturia

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SER120
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 - 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 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

Sites / Locations

  • Piedmont Medical Research Assoc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SER120

Placebo

Arm Description

SER120

Outcomes

Primary Outcome Measures

Change in Mean Number of Nocturic Episodes/Night
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline

Secondary Outcome Measures

Full Information

First Posted
July 9, 2009
Last Updated
August 28, 2020
Sponsor
Serenity Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00937859
Brief Title
Treatment of Patients With Nocturia
Official Title
A Phase III Randomized, Double Blind, Placebo Control, 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
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (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
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.

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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SER120
Arm Type
Experimental
Arm Description
SER120
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SER120
Intervention Description
SER120
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Mean Number of Nocturic Episodes/Night
Description
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
Time Frame
7 weeks
Title
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Description
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Piedmont Medical Research Assoc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

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Treatment of Patients With Nocturia

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