Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

• Status: Completed
• Trial end date: 2011-07-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Furiex Pharmaceuticals, Inc
• Treatments: Eluxadoline

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.