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NCT06819774: Phase III
Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study
Phase 3 trial testing Cetirizine Hydrochloride Injection in Acute Urticaria in 284 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | Shandong New Time Pharmaceutical Co., LTD |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 284 |
| Start date | 22 April 2024 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cetirizine Hydrochloride Injection
- Diphenhydramine Hydrochloride Injection
Conditions studied
- Acute Urticaria — all drugs for Acute Urticaria →
Sponsor
Shandong New Time Pharmaceutical Co., LTD — full company profile →
Who can join
Adults 18 to 65, any sex, with Acute Urticaria. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Scoring of the severity of pruritus
Time frame: Two hours after the treatment was completed
Scoring of the severity of pruritus
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06819774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06819774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shandong New Time Pharmaceutical Co., LTD
- Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06819774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing