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.