Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

Nocturia Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357356
• Other study ID #: SPC-SER120-DB3-201101
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Serenity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male and female 50 years or older

• Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night

Exclusion Criteria:

• CHF

• Diabetis Insipidus

• Renal Insufficiency

• Hepatic Insufficiency

• Incontinence

• Illness requiring systemic steroids

• Malignancy within the past 5 years

• Sleep Apnea

• Nephrotic Syndrome

• Unexplained Pelvic Mass

• Urinary Bladder Neurological dysfunction

• Urinary Bladder Surgery or Radiotherapy

• Pregnant or Breast Feeding

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• SER120 (750 ng/day)

• SER120 (1000 ng/day)
SER120 (1000 ng/day)
• SER120 (1500 ng/day)

• Placebo

Locations

Country	Name	City	State
United States	Serenity R&D	New City	New York

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	Change in # of Mean Nocturic Episodes Per Night	Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12	12 weeks
Primary	Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes	Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline	12 weeks