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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age range: 18 - 65 years old (inclusive of the threshold value), gender not limited;
• Diagnosed with acute urticaria (the definition of acute urticaria: spontaneous wheals and/or angioedema attacks ≤ 6 weeks);
• At screening，the severity score of pruritus of the patient was ≥ 1 point ;
• At screening，the degree score of wheals/erythema of the patient assessed by the investigator was ≥ 1 point ;
• Be willing and able to give informed consent.
Locations
Other Locations
China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2025-08
Participants
Target number of participants: 284
Treatments
Experimental: Arm 1
Cetirizine hydrochloride injection；diphenhydramine hydrochloride injection simulator
Experimental: Arm 2
diphenhydramine hydrochloride injection ；Cetirizine hydrochloride injection simulant
Related Therapeutic Areas
Sponsors
Leads: Shandong New Time Pharmaceutical Co., LTD