NCT01259128

Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Serenity Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 75 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Detailed description

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	SER120 Nasal Spray 500 ng/day	SER120 Level 1
DRUG	SER120 nasal spray 750 ng/day	SER120 (750 ng/day)

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-12-13
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

1 site across 1 country: United States