OPEN TO ENROLLMENT
Protocol Number: SPC-SER120-DB3-201101 00/2011 - Present
Sponsor: Serenity Pharmaceuticals, LLC
Title: A Randomized, Double Blind, Placebo Controlled, Parrallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients with Nocturia
Purpose of Study
Nocturia is a syndrome that has many underlying etiologies. Although some patients are unaffected by this condition, there are others who find nocturia bothersome such that it disrupts their sleep pattern and affects their quality of life. This study will evaluate the efficacy of 3 dose levels of SER120 nasal spray formulations in terms of reduction in number of nocturic episodes between screening and the treatment period in patients given SER120 versus placebo.
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Protocol Number: SPC-SER120-DB4-201301 08/2013 – Present
Title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients with Nocturia
Purpose of Study:
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia.