Status:
COMPLETED
Long Term Safety Assessment of SER120 in Patients With Nocturia
Lead Sponsor:
Serenity Pharmaceuticals, Inc.
Conditions:
Nocturia
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
Brief Summary
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
Eligibility Criteria
Inclusion
- Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
- Willing to provide consent for the study
Exclusion
- Incontinence
- Diabetes Insipidus, Diabetes Mellitus
- CHF
- Renal Insufficiency
- Significant medical history which make participation unacceptable
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00981682
Start Date
August 1 2009
End Date
August 1 2011
Last Update
January 20 2021
Active Locations (1)
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1
Stephen M. Auerbach, MD
Newport Beach, California, United States, 92660