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

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).

Timeline

Start

2010-04-28

Primary completion

2011-07-14

Completion

2011-07-14

Outcome

Met primary endpoint

registry analysis (unspecified test); Eluxadoline 25 mg; p = 0.041; Odds Ratio (OR) 2.383 (95% CI 1.036 to 5.478); ANCOVA NCT01130272 ↗

registry analysis (unspecified test); Eluxadoline 100 mg; p = 0.030; Odds Ratio (OR) 2.014 (95% CI 1.069 to 3.795); ANCOVA NCT01130272 ↗

paper Significantly more patients receiving 25 mg (12.0%) or 200 mg (13.8%) eluxadoline met the primary end point PMID 23583433 ↗

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.
• Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
• Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eluxadoline	Small molecule	5 mg	Oral
Subject	Eluxadoline	Small molecule	25 mg	Oral
Subject	Eluxadoline	Small molecule	100 mg	Oral
Subject	Eluxadoline	Small molecule	200 mg	Oral

Indications