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: 1146
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period. arm 2: Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period. arm 3: Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.

Interventions: intervention 1: Eluxadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets twice daily intervention 2: Oral tablets twice daily

Protocol document: