Back to resultsLong Term Safety Assessment of SER120 in Patients With Nocturia
Primary Purpose
Nocturia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SER120
Sponsored by
About this trial
This is an interventional treatment trial for Nocturia focused on measuring decrease in the number of nocturic episodes for patients with nocturia
Eligibility Criteria
Inclusion Criteria:
- Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
- Willing to provide consent for the study
Exclusion Criteria:
- Incontinence
- Diabetes Insipidus, Diabetes Mellitus
- CHF
- Renal Insufficiency
- Significant medical history which make participation unacceptable
Sites / Locations
- Stephen M. Auerbach, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SER120 (desmopressin)
Arm Description
Outcomes
Primary Outcome Measures
Mean Serum Sodium
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00981682
First Posted
September 18, 2009
Last Updated
December 23, 2020
Sponsor
Serenity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00981682
Brief Title
Long Term Safety Assessment of SER120 in Patients With Nocturia
Official Title
A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serenity Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
decrease in the number of nocturic episodes for patients with nocturia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
376 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SER120 (desmopressin)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SER120
Intervention Description
once a day treatment of nocturia
Primary Outcome Measure Information:
Title
Mean Serum Sodium
Description
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Time Frame
40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
Willing to provide consent for the study
Exclusion Criteria:
Incontinence
Diabetes Insipidus, Diabetes Mellitus
CHF
Renal Insufficiency
Significant medical history which make participation unacceptable
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
Long Term Safety Assessment of SER120 in Patients With Nocturia
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