Summary:
The primary objective of this 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 chronic idiopathic constipation (CIC). The secondary objective is to evaluate the effect of plecanatide on endpoints including frequency of spontaneous and complete spontaneous bowel movements, stool consistency, time to first bowel movement, and abdominal symptoms associated with constipation.
Qualified Participants Must:
• Be between 18 and 80 years of age
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Be willing and able to participate in the study for the required duration
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Understand and is willing to sign the ICF and agrees to undergo all protocol-related tests and procedures
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Be able to complete all required Daily BM and symptom electronic diary entries during the 12-week Pre-Treatment assessment period and for the duration of the study (i.e the 12-week treatment period and the 2-week Post-Treatment period)
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Have a BMI between 18 and 40 kg/m2 inclusive provided the patient does not have medical complications associated with morbid obesity.
Qualified Participants May Receive:
Reimbursement for study-related time and travel.