Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Eluxadoline; Placebo
Intervention description: Oral tablets twice daily; Oral tablets twice daily
Intervention MeSH terms: Eluxadoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1146.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Irritable bowel syndrome with diarrhea; Irritable bowel syndrome; Diarrhea predominant irritable bowel syndrome; Colonic diseases; Colonic diseases, functional; Digestive system disease; Gastrointestinal disease; Intestinal disease; Colonic pseudo-obstruction; Diarrhea; Signs and symptoms, Digestive

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is 18 to 80 years old

          2. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of
             diarrhea defined by the Rome III criteria.

        2. 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

               -  Participant has blood mixed with their stool (excluding blood from hemorrhoids).

                  3. 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.

        Exclusion Criteria:

          1. Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or
             unsubtyped IBS by the Rome III criteria.

          2. 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.

          3. Participant has a history of diverticulitis within 3 months prior to Prescreening.

          4. 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).

          5. 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.