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

Phase 3

Completed

• Conditions: Nocturia
• Interventions: Drug: SER120 750 ng; Drug: SER120 1500 ng; Drug: Placebo

• Registration Number: NCT01900704
• Lead Sponsor: Serenity Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Study Start: 2013-08
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-11
• Disposition First Submitted: 2015-11-23
• Disposition First Submitted QC: 2015-11-23
• Disposition First Posted: 2015-12-24
• Results First Submitted: 2020-08-25
• Results First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Results First Posted: 2020-11-09
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 810

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SER120 750 ng	SER120 750 ng	SER120 750 ng
SER120 1500 ng	SER120 1500 ng	SER120 1500 ng
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment	12 weeks	Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes	12 weeks	Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period

Trial Locations

Locations (1)

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