Chronic Idiopathic Constipation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.
The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral
Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo,
when administered for 8 weeks in adolescents with chronic idiopathic constipation.
This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week
follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and
other clinical features of CIC.
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