12-Week Study of Plecanatide for CIC (The 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

NCT01982240

Run by

Bausch Health Americas, Inc.

People needed

1394

Starts

2013-11-01

Expected to finish

2015-06-01

Last updated by the study team

2019-12-26

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 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 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 MI within 60 days of screening
• Participated in a previous plecanatide clinical trial

Where it is running

• Synergy Research Site — Dothan, Alabama, United States
• Synergy Research Site — Gulf Shores, Alabama, United States
• Synergy Research Site — Huntsville, Alabama, United States
• Synergy Research Site — Mobile, Alabama, United States
• Synergy Research Site — Mesa, Arizona, United States
• Synergy Research Site — Phoenix, Arizona, United States
• Synergy Research Site — Phoenix, Arizona, United States
• Synergy Research Site — Tempe, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Hot Springs, Arkansas, United States
• Synergy Research Site — Little Rock, Arkansas, United States
• Synergy Research Site — North Little Rock, Arkansas, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Carlsbad, California, United States
• Synergy Research Site — Cerritos, California, United States
• Synergy Research Site — Chula Vista, California, United States
• Synergy Research Site — El Cajon, California, United States
• Synergy Research Site — Encinitas, California, United States
• Synergy Research Site — Encino, California, United States
• Synergy Research Site — Fountain Valley, California, United States
• Synergy Research Site — Fresno, California, United States
• Synergy Research Site — Hawaiian Gardens, California, United States
• Synergy Research Site — Lancaster, California, United States
• Synergy Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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