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

Inclusion Criteria

• •1. 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 or
• •* 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.