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A Phase III, Multi-center, Double Blind, Randomized, Active Controlled Clinical Trial to Evaluate the Non-Inferiority Comparing Cetirizine Injection 10 mg to Diphenhydramine Injection, 50 mg, for the Treatment of Acute Urticaria

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Trial Profile

A Phase III, Multi-center, Double Blind, Randomized, Active Controlled Clinical Trial to Evaluate the Non-Inferiority Comparing Cetirizine Injection 10 mg to Diphenhydramine Injection, 50 mg, for the Treatment of Acute Urticaria

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2020

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At a glance

  • Drugs Cetirizine (Primary) ; Diphenhydramine
  • Indications Urticaria
  • Focus Registrational; Therapeutic Use
  • Sponsors JDP Therapeutics

Most Recent Events

  • 01 Oct 2020 Results establishing the noninferiority of intravenous cetirizine relative to intravenous diphenhydramine and Post hoc analysis of primary efficacy endpoints among elderly patients, published in the Annals of Emergency Medicine
  • 18 Feb 2019 According to a JDP Therapeutics media release, the U.S. FDA has accepted the New Drug Application (NDA) for QUZYTTIR (IV cetirizine) for the use of this product to treat acute urticaria in adults and children.Similar filings and regulatory registrations will be pursued for Canada, Europe and rest of the world.
  • 14 Dec 2018 Status changed from recruiting to completed.

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