Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

Summary

This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.

Timeline

Start

2017-03-01

Primary completion

2018-04-30

Completion

2018-04-30

Outcome

Met primary endpoint

paper intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3) PMID 32653333 ↗

Publications

• Abella BS, Berger WE, Blaiss MS, Stiell IG, Herres JP, Moellman JJ, Suner S, Kessler A, Klausner HA, Caterino JM, Du J. Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial. Ann Emerg Med. 2020 Oct;76(4):489-500. doi: 10.1016/j.annemergmed.2020.05.025. Epub 2020 Jul 9.

Drugs

Indications