- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00981682
Long Term Safety Assessment of SER120 in Patients With Nocturia
December 23, 2020 updated by: Serenity Pharmaceuticals, Inc.
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
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
376
Phase
- 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
-
-
California
-
Newport Beach, California, United States, 92660
- Stephen M. Auerbach, MD
-
-
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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SER120 (desmopressin)
|
once a day treatment of nocturia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Serum Sodium
Time Frame: 40 weeks
|
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
|
40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
September 18, 2009
First Submitted That Met QC Criteria
September 21, 2009
First Posted (Estimate)
September 22, 2009
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
December 23, 2020
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPC-SER120-OL1-200903
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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-
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-
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Wellesley Pharmaceuticals, LLCCompleted
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Corporacion Parc TauliCompleted
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Clinical Trials on SER120
-
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-
Serenity Pharmaceuticals, Inc.Completed
-
Serenity Pharmaceuticals, Inc.Completed
-
Serenity Pharmaceuticals, Inc.Completed