Conditions: Irritable Bowel Syndrome
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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 807
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. arm 2: Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. . arm 3: Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. arm 4: Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. arm 5: Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.

Interventions: intervention 1: Eluxadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, orally, twice daily. intervention 2: Matching placebo oral tablets twice daily.

Protocol document: