Long Term Safety Assessment of SER120 in Patients With Nocturia

Phase 3

Completed

• Conditions: Nocturia
• Interventions: Drug: SER120

• Registration Number: NCT00981682
• Lead Sponsor: Serenity Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Disposition First Submitted: 2013-12-19
• Status Verified: 2014-01
• Disposition First Submitted QC: 2014-01-27
• Disposition First Posted: 2014-02-28
• Results First Submitted: 2020-12-23
• Results First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Results First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SER120 (desmopressin)	SER120	-

Primary Outcome Measures

Name	Time	Method
Mean Serum Sodium	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

Trial Locations

Locations (1)

Stephen M. Auerbach, MD; 🇺🇸 Newport Beach, California, United States