Treatment of Patients With Nocturia (Non-PK Study)

Phase 3

Completed

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

• Registration Number: NCT00937378
• 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: 2010-08
• Study Completion: 2010-08
• 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: 2020-08-27
• Results First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Number of Nocturic Episodes/Night	7 weeks	Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
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

Trial Locations

Locations (1)

University Urology Associates; 🇺🇸 New York, New York, United States