Clinical Trial: Treatment of Patients With Nocturia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Serenity Pharmaceuticals, Inc.

Current Primary Outcome: number of nocturic episodes [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: proportion of nights with less than or equal to one nocturic episode [ Time Frame: 4 weeks ]

Original Secondary Outcome: Same as current

Information By: Serenity Pharmaceuticals, Inc.

Dates:
Date Received: July 9, 2009
Date Started: June 2009
Date Completion:
Last Updated: April 24, 2014
Last Verified: April 2014