12-Week Study of Plecanatide for CIC (The National CIC3 Study)

Exclusion Criteria

• •Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of Bowel Movements (BMs) during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment
• •Active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable
• •History of cathartic colon, laxative, enema abuse, or ischemic colitis
• •Fecal impaction within 3 months of screening
• •Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
• •Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis
• •Major surgery, stroke or myocardial infarction (MI) within 60 days of screening
• •Participated in a previous plecanatide clinical trial