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

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.

Timeline

Start

2012-05-29

Primary completion

2014-07-29

Completion

2014-07-29

Outcome

Met primary endpoint

paper more patients in the eluxadoline groups (75 mg and 100 mg) than in the placebo group reached the primary end point PMID 26789872 ↗

registry analysis (superiority test); Eluxadoline 75 mg vs Placebo; p = 0.014; Chi-square test statistic; note: Significance level of 0.025 NCT01553591 ↗

registry analysis (superiority test); Eluxadoline 100 mg vs Placebo; p = 0.004; Chi-square test statistic; note: Significance level of 0.025 NCT01553591 ↗

Publications

• Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
• Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eluxadoline	Small molecule	75 mg	Oral
Subject	Eluxadoline	Small molecule	100 mg	Oral

Indications