Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Key facts

Study ID

NCT01553591

Run by

Furiex Pharmaceuticals, Inc

People needed

1282

Starts

2012-05-29

Expected to finish

2014-07-29

Last updated by the study team

2018-09-04

Who can join

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

You may qualify if…

• Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
• Participant has had a colonoscopy performed:
• Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
• Since the onset (if applicable) of any of the following alarm features for participants of any age:
• Participant has documented weight loss within the past 6 months
• Participant has nocturnal symptoms
• Participant has a familial history of first-degree relatives with colon cancer or
• Participant has blood mixed with their stool (excluding blood from hemorrhoids).
• Female participants must be:
• Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
• Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
• Abstinent, or
• If sexually active, be practicing an effective method of birth control.

You may not qualify if…

• Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
• Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
• Participant has a history of diverticulitis within 3 months prior to Prescreening.
• Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
• Participant has any of the following surgical history:
• Cholecystectomy with any history of post cholecystectomy biliary tract pain
• Any abdominal surgery within the 3 months prior to Prescreening
• Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)
• Other protocol-specific eligibility criteria may apply.

Where it is running

• Furiex Research Site — Birmingham, Alabama, United States
• Furiex Research Site — Foley, Alabama, United States
• Furiex Research Site — Huntsville, Alabama, United States
• Furiex Research Site — Ozark, Alabama, United States
• Furiex Research Site — Chandler, Arizona, United States
• Furiex Research Site — Glendale, Arizona, United States
• Furiex Research Site — Mesa, Arizona, United States
• Furiex Research Site — Phoenix, Arizona, United States
• Furiex Research Site — Tucson, Arizona, United States
• Furiex Research Site — Little Rock, Arkansas, United States
• Furiex Research Site — Little Rock, Arkansas, United States
• Furiex Research Site — North Little Rock, Arkansas, United States
• Furiex Research Site — Azusa, California, United States
• Furiex Research Site — Bell Gardens, California, United States
• Furiex Research Site — Beverly Hills, California, United States
• Furiex Research Site — Carson, California, United States
• Furiex Research Site — Chula Vista, California, United States
• Furiex Research Site — Corona, California, United States
• Furiex Research Site — El Cajon, California, United States
• Furiex Research Site — Encino, California, United States
• Furiex Research Site — Garden Grove, California, United States
• Furiex Research Site — Lomita, California, United States
• Furiex Research Site — Los Angeles, California, United States
• Furiex Research Site — Monterey Park, California, United States
• Furiex Research Site — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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