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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Scoring of the severity of pruritus [Срок оценки: Two hours after the treatment was completed]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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);
• Patients with acute urticaria accompanied by fever during screening;
• Patients engaged in dangerous jobs such as driving, high-altitude work, mechanical operation, etc., and cannot stop within 48 hours after medication;
• Other various situations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese Academy of Medical Sciences, Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06819774 · NTP-XTLQ-I-Ⅲ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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