Phase 3
N=376
Long Term Safety Assessment of SER120 in Patients With Nocturia
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT00981682 ↗Enrolled (actual)
376
Serious AEs
8.0%
Results posted
Jan 2021
Primary outcome: Primary: Mean Serum Sodium — -0.0; -0.4; -0.4; -0.3 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SER120 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Serenity Pharmaceuticals, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Sodium |
-0.0; -0.4; -0.4; -0.3; -0.5; -0.4 | — |
Summary
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
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
Data sourced from ClinicalTrials.gov (NCT00981682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.