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

NCT06819774 | Recruiting Phase 3

• 1 other identifier: NTP-XTLQ-I-Ⅲ
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cetirizine hydrochloride injection; acute urticatia

Outcome Measures

Primary Outcomes (1)

• Scoring of the severity of pruritus

  Scoring of the severity of pruritus

  Two hours after the treatment was completed

Study Arms (2)

Arm 1

EXPERIMENTAL

Cetirizine hydrochloride injection；diphenhydramine hydrochloride injection simulator

Drug: Cetirizine Hydrochloride Injection

Arm 2

EXPERIMENTAL

diphenhydramine hydrochloride injection ；Cetirizine hydrochloride injection simulant

Drug: Diphenhydramine Hydrochloride Injection

Interventions

Cetirizine Hydrochloride Injection DRUG

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.

Also known as: Simulant of Diphenhydramine Hydrochloride Injection

Arm 1

Diphenhydramine Hydrochloride Injection DRUG

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.

Also known as: Simulant of Cetirizine Hydrochloride Injection

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients who received steroid hormone treatment for acute allergic reactions within 4 hours before randomization;
• Patients who used epinephrine within 20 minutes before randomization;
• Patients who are known to be allergic to hydroxyzine, cetirizine, levocetirizine, diphenhydramine;
• Pregnant or lactating women; or those who have a pregnancy plan or plan to donate sperm/eggs from the screening day to the end of medication within 1 month; or those who are unwilling to take one or more contraceptive measures from the screening day to the end of medication within 1 month;
• Patients with urticarial drug eruption;
• Patients with acute urticaria who have concurrent symptoms such as laryngeal edema, allergic asthma, anaphylactic shock during screening;
• Patients with urticarial vasculitis, hereditary angioedema, antihistamine-resistant urticaria or skin diseases that interfere with the evaluation of treatment efficacy during screening;
• Patients with a history of immunodeficiency;
• Patients with other major medical conditions (such as blood diseases, cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, etc.) or mental disorders and judged by the investigator to be unsuitable to participate in this study;
• Patients who are concurrently using P-glycoprotein inhibitors (such as cyclosporine, itraconazole, dronedarone, amiodarone, quinidine, verapamil, etc.) during screening;
• Patients who participated in other clinical trials within 3 months before screening (excluding those who only participated in the screening of the clinical trial but did not use the trial drugs or devices);

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

Cetirizine; Diphenhydramine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: April 22, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)