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Clinical Trials Update
March 22/29, 2016

A New Option for Treating IBS With Diarrhea

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(12):1220. doi:10.1001/jama.2016.2488

According to findings from two phase 3 trials, treatment with eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), decreased symptoms in patients with irritable bowel syndrome (IBS) with diarrhea (Lembo AJ et al. N Engl J Med. 2016;374[3]:242-253).

The 2427 adults in the trial were randomly assigned to receive treatment with eluxadoline (75 mg or 100 mg) or placebo twice daily for 26 weeks or 52 weeks. The primary end point was an improvement in abdominal pain and stool consistency on the same day for at least 50% of the days from weeks 1 through 12 (the US Food and Drug Administration end point for treatment effect) and from weeks 1 through 26 (the European Medicines Agency end point).

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