Actively Recruiting
Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2025-02-11
284
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 (inclusive)
- Diagnosed with acute urticaria defined as spontaneous wheals and/or angioedema attacks 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 (e.g., angle-closure glaucoma, 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 or lactating women, or planning pregnancy or sperm/egg donation within 1 month of medication
- Unwillingness to use contraception from screening to 1 month after medication
- Urticarial drug eruption
- Acute urticaria with laryngeal edema, allergic asthma, or anaphylactic shock during screening
- Urticarial vasculitis, hereditary angioedema, antihistamine-resistant urticaria, or interfering skin diseases
- History of immunodeficiency
- Major medical conditions or mental disorders judged unsuitable by investigator
- Concurrent use of P-glycoprotein inhibitors during screening
- Participation in other clinical trials within 3 months before screening (except screening only)
- Acute urticaria accompanied by fever during screening
- Engaged in dangerous jobs unable to stop within 48 hours after medication
- Other various situations as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here