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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

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

Key facts

Study ID

NCT02122471

Run by

Bausch Health Americas, Inc.

People needed

1410

Starts

2014-04-01

Expected to finish

2015-07-01

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18-80, inclusive
• Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
• Completed a colonoscopy in accordance with American Gastroenterological Association (AGA) colon cancer screening guidelines (5 years), with no clinically significant findings
• Willing to maintain a stable diet during the study

You may not qualify if…

• 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

Where it is running

• Synergy Research Site — Huntsville, Alabama, United States
• Synergy Research Site — Chandler, Arizona, United States
• Synergy Research Site — Goodyear, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Artesia, California, United States
• Synergy Research Site — Carmichael, California, United States
• Synergy Research Site — Corona, California, United States
• Synergy Research Site — Encino, California, United States
• Synergy Research Site — Garden Grove, California, United States
• Synergy Research Site — Garden Grove, California, United States
• Synergy Research Site — Glendale, California, United States
• Synergy Research Site — La Mirada, California, United States
• Synergy Research Site — Laguna Hills, California, United States
• Synergy Research Site — Los Angeles, California, United States
• Synergy Research Site — Los Angeles, California, United States
• Synergy Research Site — Newport Beach, California, United States
• Synergy Research Site — Oceanside, California, United States
• Synergy Research Site — Orange, California, United States
• Synergy Research Site — Sacramento, California, United States
• Synergy Research Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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