The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Key facts

Study ID

NCT01429987

Run by

Bausch Health Americas, Inc.

People needed

951

Starts

2011-10-01

Expected to finish

2012-12-01

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18-75, inclusive
• Body Mass Index = 18-35 kg/m2, inclusive
• Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
• Less than 3 CSBMs per week at baseline and during pretreatment
• Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
• Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
• Willing to maintain a stable diet during the study.
• Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into 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 treatment period
• Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
• Active peptic ulcer disease 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 within 60 days of screening.

Where it is running

• East Valley Gastroenterology and Hepatology Associates, PC — Chandler, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Desert Sun Clinical Research, LLC — Tucson, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Preferred Research Partners, Inc — Little Rock, Arkansas, United States
• ACRI-Phase 1,LLC — Anaheim, California, United States
• Translational Research Group, INC., d/b/a Providence Clinical Research — Burbank, California, United States
• GW Research, Inc — Chula Vista, California, United States
• Community Clinical Trials — Orange, California, United States
• Dormir Clinical Trials, Inc — Redlands, California, United States
• Inland Gastroenterology Medical Associates, Inc. — Redlands, California, United States
• Superior Research LLC — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Progressive Clinical Research — Vista, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Consultants for Clinical Research of S. Florida — Boynton Beach, Florida, United States
• Medical Research Unlimited, LLC — Hialeah, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Jupiter Research, Inc. — Jupiter, Florida, United States
• Miami Gastroenterology Consultants, PA — Miami, Florida, United States
• Advance Medical Research Service Corp — Miami, Florida, United States
• Advance Medical Research Service — Miami, Florida, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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