A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)

Phase 2 Completed 60 enrolled GW Research Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was conducted to determine the efficacy and safety of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a Mayo score of 2 or less (with no sub-score \>1) after 10 weeks of treatment.

Timeline

Start: 2012-05-09
Primary completion: 2014-08-05
Completion: 2014-08-05

Outcome

Missed primary endpoint

paper The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). PMID 29538683 ↗

registry analysis (superiority or other test); GWP42003 vs Placebo; p = 0.7532; Odds Ratio (OR) 0.821 (90% CI 0.292 to 2.309); Regression, Logistic NCT01562314 ↗

registry analysis (superiority or other test); GWP42003 vs Placebo; p = 0.7032; Odds Ratio (OR) 1.300 (90% CI 0.419 to 4.040); Regression, Logistic NCT01562314 ↗

Publications

Results Irving PM, Iqbal T, Nwokolo C, Subramanian S, Bloom S, Prasad N, Hart A, Murray C, Lindsay JO, Taylor A, Barron R, Wright S. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis. Inflamm Bowel Dis. 2018 Mar 19;24(4):714-724. doi: 10.1093/ibd/izy002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	250 mg	Oral