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
- 2014-01-09
- Completion
- 2014-01-09
Outcome
Met primary endpoint
paper For weeks 1 through 12, 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 <0.001; Chi-square test statistic; note: Significance level of 0.025 NCT01553747 ↗
registry analysis (superiority test); Eluxadoline 100 mg vs Placebo; p <0.001; Chi-square test statistic; note: Significance level of 0.025 NCT01553747 ↗
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 |