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NCT01900704 Clinical Trial

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4

Nocturia Clinical Trial

— DB4  

Official title:
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01900704
Other study ID # SPC-SER120-DB4-201301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2013
Est. completion date April 2015

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

Clinical Trial Summary

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Recruitment information / eligibility
Status Completed
Enrollment 810
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years to 95 Years
Eligibility Inclusion Criteria: - Male and female 50 years or older - Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night Exclusion Criteria: - CHF - Diabetis Insipidus - Renal insufficiency - Hepatic insufficiency - Incontinence - Illnesses 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SER120 750 ng
SER120 750 ng
• SER120 1500 ng
SER120 1500 ng
• Placebo
Placebo

Locations
Country Name City State
United States Stephen M. Auerbach, MD Newport Beach California

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 Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment 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 Equal of Greater Than 50% Reduction in Mean Nocturic Episodes Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period 12 weeks
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