Chronic Idiopathic Constipation Clinical Trial
Official title:
A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
This is a national, randomized, 12-week, double-blind, placebo-controlled, study in
approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide
to placebo. The study will be conducted at approximately 180 clinical study sites in the
United States. The primary objective of the study is to evaluate the efficacy and safety of
3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of
patients with CIC. The study population will include only patients without other causes of
constipation or other chronic conditions that could interfere with study assessments.
Patients may not take laxatives (with the exception of the study-provided rescue medication,
bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation
or diarrhea, during study participation.
There are 6 scheduled study visits, including the screening and follow-up visits. The planned
duration of participation in this study will be 112 days and up to 155 days, with washout and
all visit windows considered.
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