Conditions: Chronic Idiopathic Constipation
Keywords: CIC Constipation Chronic Constipation Synergy Plecanatide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1394
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Detailed description:
This is a 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 (US) and Canada. 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.

Arms:
arm 1: Plecanatide tablets 3.0 mg QD for 12 weeks arm 2: Plecanatide tablets 6.0 mg QD for 12 weeks arm 3: Matching placebo tablets QD for 12 weeks arm 4: Rescue medication

Interventions: intervention 1: Plecanatide intervention 2: Placebo intervention 3: Bisacodyl
Intervention descriptions: intervention 1: Plecanatide tablets QD for 12 weeks intervention 2: Matching placebo tablets QD for 12 weeks intervention 3: Rescue medication

Protocol document: