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

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259128
• Other study ID #: SPC-SER120-ELD-2010-01
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: November 2010

Study information

• Verified date: April 2014
• Source: Serenity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 95 Years

Eligibility

Inclusion Criteria:

• Male & female greater or equal to 75 years of age, history of nocturia

Exclusion Criteria:

• CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome

• Unexplained pelvic masses

• Urinary bladder surgery or radiotherapy

• Sleep apnea

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• SER120 Nasal Spray 500 ng/day
SER120 Level 1
• SER120 nasal spray 750 ng/day
SER120 (750 ng/day)

Locations

Country	Name	City	State
United States	Dr. Jolene Berg	San Antonio	Texas

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	Serum Sodium Levels at Baseline and During Treatment	Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.	baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Secondary	Change in Mean Nocturic Episodes Per Night	Change in mean nocturic episodes per night between baseline and Week 8	Mean value at Week 8 minus mean value at baseline
Secondary	Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes	Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline	8 weeks