Treatment of Patients With Nocturia

Phase 3

Completed

• Conditions: Nocturia
• Interventions: Drug: SER120; Drug: Placebo

• Registration Number: NCT00937859
• Lead Sponsor: Serenity Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Disposition First Submitted: 2013-12-19
• Disposition First Submitted QC: 2014-01-27
• Disposition First Posted: 2014-02-28
• Status Verified: 2014-04
• Results First Submitted: 2020-08-28
• Results First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Results First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Male and female 50 years or older
• Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria

• CHF
• Diabetes
• Diabetes Insipidus
• Renal Insufficiency
• Hepatic Insufficiency
• Incontinence
• Illness requiring steroids
• Current or past urologic malignancy
• Nephrotic Syndrome
• Unexplained pelvic masses
• Urinary bladder neurological dysfunction
• Urinary bladder surgery or radiotherapy
• Sleep Apnea
• Pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SER120	SER120	SER120
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night	7 weeks	Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Change in Mean Number of Nocturic Episodes/Night	7 weeks	Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline

Trial Locations

Locations (1)

Piedmont Medical Research Assoc.; 🇺🇸 Winston-Salem, North Carolina, United States