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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShandong New Time Pharmaceutical Co., LTD

About this trial

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 criteria

Qualifiers

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 ;

Disqualifiers

Patients in whom an antihistamine are contraindicated (such as those with angle-closure glaucoma, symptomatic benign prostatic hyperplasia, etc.);

Patients who used H1 antagonists (such as diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine, etc.) within 2 hours before randomization;

Patients who used H2 antagonists (such as cimetidine, ranitidine, famotidine, roxatidine, etc.) within 2 hours before randomization;

Patients who used doxepin within 2 hours before randomization;

Trial design

Treatments tested in this trial

  • Cetirizine Hydrochloride Injection
  • Diphenhydramine Hydrochloride Injection

Treatment groups

284 Participants
are divided into 2 treatment groups