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New treatment option for Acute Urticaria
Official title Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria
ClinicalTrials.gov ID: NCT06819774
What this study is testing
What is Cetirizine Hydrochloride Injection?
Cetirizine Hydrochloride Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute urticaria.
Also referred to as Simulant of Diphenhydramine Hydrochloride Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join 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...
- 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;
See the full eligibility criteria
- 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.
- 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...
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.