Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring 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
Eligibility Criteria
Key Inclusion Criteria:
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
- Female patients must be:
- postmenopausal, defined as amenorrhea 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.
Key Exclusion Criteria:
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
- Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
- Patient has a history of diverticulitis within 6 months prior to Prescreening
- Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.
Other protocol-specific eligibility criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Eluxadoline 5 mg
Eluxadoline 25 mg
Eluxadoline 100 mg
Eluxadoline 200 mg
Placebo
Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.