Affiliation:
1. David Geffen School of Medicine UCLA Los Angeles California USA
2. University of Texas Health Science Center Houston Houston Texas USA
3. Beth Israel Deaconess Medical Center Boston Massachusetts USA
4. University of California San Diego La Jolla California USA
5. Arena Pharmaceuticals, Inc. San Diego California USA
6. Sharp Grossmont Hospital San Diego California USA
7. University Hospitals Leuven Leuven Belgium
Abstract
AbstractBackgroundOlorinab is a highly selective, peripherally acting, full agonist of cannabinoid receptor 2. This study assessed the efficacy and safety of olorinab to treat abdominal pain in patients with irritable bowel syndrome with diarrhea (IBS‐D) and constipation (IBS‐C).MethodsCAPTIVATE was a phase 2b, randomized, double‐blind, placebo‐controlled, parallel‐group trial. Eligible participants aged 18–70 years with IBS‐C and IBS‐D diagnosed per Rome IV received olorinab 10 mg, 25 mg, or 50 mg three times daily (TID) or placebo TID for 12 weeks. The primary endpoint was the change in patient‐reported average abdominal pain score (AAPS) from baseline to Week 12.Key ResultsA total of 273 participants were randomized to receive olorinab 10 mg (n = 67), olorinab 25 mg (n = 67), olorinab 50 mg (n = 69), or placebo (n = 70). Although a treatment response was observed across all groups, the weekly change in average AAPS from baseline to Week 12 was not significantly different between placebo and any olorinab dose. In a prespecified subgroup analysis of participants with a baseline AAPS ≥6.5, olorinab 50 mg (n = 35) significantly improved AAPS compared with placebo (n = 30) (p = 0.014). Adverse event rates were comparable between olorinab and placebo and there were no reported serious adverse events or deaths.Conclusion and InferencesAlthough olorinab was well‐tolerated and improved weekly AAPS, the primary endpoint was not met. However, in participants with moderate‐to‐severe pain at baseline (AAPS ≥6.5), olorinab 50 mg significantly improved weekly AAPS compared with placebo. ClinicalTrials.gov: NCT04043455.
Subject
Gastroenterology,Endocrine and Autonomic Systems,Physiology
Cited by
8 articles.
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