The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome Characterized by Constipation

In brief

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.

Key facts

Study ID

NCT01722318

Run by

Bausch Health Americas, Inc.

People needed

428

Starts

2012-11-01

Expected to finish

2014-10-01

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 irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
• Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
• Hard or lumpy stools ≥ 25 % of defecations
• Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
• 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 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 period
• Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
• 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: 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

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• Arrowhead Family Health Center PC dba Arrowhead Health Centers — Glendale, Arizona, United States
• Advanced Research Associates, LLC — Glendale, Arizona, United States
• Elite Clinical Trials, LLC — Phoenix, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Advanced Rx Clinical Research, Inc. — Artesia, California, United States
• GW Research, Inc. — Chula Vista, California, United States
• SC Clinical Research, Inc. — Garden Grove, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Community Clinical Trials — Orange, California, United States
• Healthcare Partners Medical Group — Pasadena, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Memorial Research Medical Clinic d/b/a Orange Country Research Center — Tustin, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Medical Research Unlimited, LLC — Hialeah, Florida, United States
• Eastern Research, Inc — Hialeah, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Jupiter Research, Inc. — Jupiter, Florida, United States
• MNH Surgical Center — Maitland, Florida, United States
• Cahaba Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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