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Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2025-02-11
284
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of cetirizine hydrochloride injection compared to diphenhydramine hydrochloride injection in treating acute urticaria, which involves sudden wheals and/or angioedema lasting up to six weeks. This is a randomized, double-blind, positive-controlled Phase III clinical study sponsored by Shandong New Time Pharmaceutical Co., LTD aimed at improving treatment options for this condition. Participants receive a single dose of either cetirizine hydrochloride injection administered by intravenous push along with a simulated diphenhydramine injection by deep intramuscular injection, or diphenhydramine hydrochloride injection by deep intramuscular injection with a simulated cetirizine injection by rapid intravenous injection. These treatments are designed to mimic single administrations in two study arms for comparison. During the study, participants' severity of itching (pruritus) is scored two hours after treatment completion. Researchers monitor safety and efficacy closely, with assessments including symptom severity scores and adverse event tracking. The study enrolls adults aged 18 to 65 with acute urticaria and continues until August 2025, providing careful observation of treatment effects and participant health throughout the trial.
CONDITIONS
Brief Title
Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Diagnosed with acute urticaria with spontaneous wheals and/or angioedema lasting 6 weeks or less
- Pruritus severity score of at least 1 point at screening
- Wheals/erythema severity score of at least 1 point at screening
- Willing and able to provide informed consent
You will not qualify if you...
- Contraindication to antihistamines such as angle-closure glaucoma or symptomatic benign prostatic hyperplasia
- Use of H1 antagonists within 2 hours before randomization
- Use of H2 antagonists within 2 hours before randomization
- Use of doxepin within 2 hours before randomization
- Steroid hormone treatment for acute allergic reactions within 4 hours before randomization
- Use of epinephrine within 20 minutes before randomization
- Known allergy to hydroxyzine, cetirizine, levocetirizine, or diphenhydramine
- Pregnant, lactating, planning pregnancy, or unwilling to use contraception during the study
- Urticarial drug eruption
- Concurrent symptoms like laryngeal edema, allergic asthma, or anaphylactic shock at screening
- Urticarial vasculitis, hereditary angioedema, antihistamine-resistant urticaria, or interfering skin diseases
- History of immunodeficiency
- Major medical or mental conditions deemed unsuitable by investigator
- Use of P-glycoprotein inhibitors during screening
- Participation in other clinical trials within 3 months before screening
- Acute urticaria with fever at screening
- Engaged in dangerous jobs unable to stop within 48 hours after medication
- Other various disqualifying situations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of either cetirizine hydrochloride injection or diphenhydramine hydrochloride injection as part of the study treatment.
1 treatment visit (in-person)
Duration - Hours after treatment
Participants are monitored for safety and efficacy outcomes, including assessment of pruritus severity two hours after treatment completion.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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