Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Phase 2 Terminated 273 enrolled Arena Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).

Timeline

Start: 2019-07-24
Primary completion: 2021-04-29
Completion: 2021-04-29

Outcome

Missed primary endpoint

Stopped (Business): “Business Decision”

paper the primary endpoint was not met. PMID 36740814 ↗

registry p =0.172; Least square mean difference -0.55 (95% CI -1.34 to 0.24) NCT04043455 ↗

Publications

Chang L, Cash BD, Lembo A, Kunkel DC, English BA, Lindstrom B, Gu G, Skare S, Gilder K, Turner S, Cataldi F, Lipkis D, Tack J. Efficacy and safety of olorinab, a full agonist of the cannabinoid receptor 2, for the treatment of abdominal pain in patients with irritable bowel syndrome: Results from a phase 2b randomized placebo-controlled trial (CAPTIVATE). Neurogastroenterol Motil. 2023 May;35(5):e14539. doi: 10.1111/nmo.14539. Epub 2023 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olorinab	Small molecule	10 mg	Oral
Subject	Olorinab	Small molecule	25 mg	Oral
Subject	Olorinab	Small molecule	50 mg	Oral