efficacy of eluxadoline in the treatment of irritable bowel syndrome with diarrhea in patients with inadequate control of symptoms with prior loperamide use

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: this study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (bid) versus placebo for the treatment of patients with irritable bowel syndrome with diarrhea (ibs-d) who report that the use of loperamide in the prior 12 months failed to provide control of their ibs-d symptoms.


Eligibility criteria:
inclusion criteria: * has a diagnosis of ibs-d, defined by the rome iii criteria as loose (mushy) or watery stools ≥25% and hard or lumpy stools ≤25% of bowel movements. * has had a colonoscopy performed within 5 years prior to screening if they are at least 50 years of age, or if they meet any of the following alarm features: 1. has documented weight loss within the past 6 months; or 2. has nocturnal symptoms; or 3. has a familial history of colon cancer; or 4. has blood mixed with their stool (excluding any blood from hemorrhoids) * patient reports use of loperamide in the 12 months prior to screening for ibs-d symptoms and that loperamide did not provide adequate control of ibs-d symptoms. * has not used any loperamide rescue medication within 14 days prior to randomization. exclusion criteria: * has a diagnosis of irritable bowel syndrome (ibs) with a subtype of constipation ibs, mixed ibs, or unsubtyped ibs. * has a history of inflammatory or immune-mediated gastrointestinal (gi) disorders including inflammatory bowel disease (i.e., crohn's disease, ulcerative colitis), microscopic colitis, or celiac disease. * has a history of diverticulitis within 3 months prior to screening. * has a documented history of lactose intolerance. * has a documented history of bile-acid malabsorption. * has a history of chronic or severe constipation or intestinal obstruction, stricture, toxic megacolon, gi perforation, fecal impaction, gastric banding, bariatric surgery, adhesions. * has any of the following surgical history: 1. cholecystectomy or previously documented agenesis of gallbladder; or 2. any abdominal surgery within the 3 months prior to screening; or 3. major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed). * has a history of cholecystitis within 6 months before screening. * has a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction. * has a history of known or suspected biliary duct obstruction or sphincter of oddi disease or dysfunction, excluding a history of gallstones. * has a history or current evidence of laxative abuse within 5 years prior to screening. * has documented evidence of cirrhosis. * has a history of cardiovascular events, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to screening. * has an unstable renal, hepatic, metabolic, or hematologic condition. * has a history of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ). * has a history of human immunodeficiency virus infection. * has a history of diagnostic and statistical manual of mental disorders, 4th edition, text revision-defined substance dependency, excluding nicotine and caffeine, within 2 years prior to screening. * has a history of alcohol abuse, alcohol addiction, and alcoholism or drinks more than 3 alcoholic beverages per day. * has used aspirin or aspirin-containing medications (\>325 mg of aspirin per day) or nonsteroidal anti-inflammatory drugs, when taken specifically for the symptoms of ibs, within 14 days of randomization. * has current (within 14 days of randomization) or expected use of any narcotic or opioid-containing agents, tramadol, docusate, enemas, gi preparations (including antacids containing aluminum or magnesium, antidiarrheal agents \[except loperamide rescue medication after randomization\]), antinausea agents, antispasmodic agents, bismuth, or prokinetic agents. * has current (within 28 days of randomization) use of rifaximin or other antibiotics (with the exception of topical antibiotics or a 1-day course with an antibiotic). expected use of rifaximin or other antibiotics during the course of the study that is known at the time of randomization. * has an elective surgery planned or expects to need elective surgery at any time during the study.