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NCT00981682 Clinical Trial

Long Term Safety Assessment of SER120 in Patients With Nocturia

Nocturia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00981682
Other study ID # SPC-SER120-OL1-200903
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2009
Est. completion date August 2011

Study information
Verified date January 2014
Source Serenity Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Recruitment information / eligibility
Status Completed
Enrollment 376
Est. completion date August 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• SER120
once a day treatment of nocturia

Locations
Country Name City State
United States Stephen M. Auerbach, MD Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
Serenity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 40 weeks
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