NCT06819774

Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria

Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria.The participants were randomized to receive cetirizine hydrochloride or diphenhydramine hydrochloride.

Conditions

• Acute Urticaria

Interventions

Type	Name	Description
DRUG	Cetirizine Hydrochloride Injection	The subjects received a single dose of 1-2 ml of the injection of cetirizine hydrochloride (administered by intravenous push) and a 1 ml dose of the injection simulant of diphenhydramine hydrochloride (administered by deep intramuscular injection), both as a simulation of a single administration.
DRUG	Diphenhydramine Hydrochloride Injection	The subjects received 1 ml of the injection of Diphenhydramine Hydrochloride (for deep intramuscular injection) and 1 ml of the injection of Simulated Cetirizine Hydrochloride (administered by rapid intravenous injection over 1 to 2 minutes), each as a single dose.

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: China