Acute UrticariaPhase 3Phase IIINCT06819774
Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria
A Phase 3 study testing Cetirizine Hydrochloride Injection and Diphenhydramine Hydrochloride Injection in people with Acute Urticaria, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Urticaria
- What is being tested?
- Cetirizine Hydrochloride Injection and Diphenhydramine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to Aug 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Jin Dr, 010-69151500, jinhongzhong@263.net
About this study
Official title: Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study
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
- Acute Urticaria
- Being tested
- Cetirizine Hydrochloride Injection, Diphenhydramine Hydrochloride Injection
- Keywords
- Cetirizine hydrochloride injection, acute urticatia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine Hydrochloride InjectionDrug
Also called Simulant of Diphenhydramine 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.
Diphenhydramine Hydrochloride InjectionDrug
Also called Simulant of Cetirizine 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Cetirizine hydrochloride injection；diphenhydramine hydrochloride injection simulator Receives: Drug: Cetirizine Hydrochloride Injection |
| Arm 2 | Experimental | diphenhydramine hydrochloride injection ；Cetirizine hydrochloride injection simulant Receives: Drug: Diphenhydramine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring of the severity of pruritus
Scoring of the severity of pruritus
Measured: Two hours after the treatment was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start22 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute UrticariaStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819774
- Sponsor's protocol ID
- NTP-XTLQ-I-Ⅲ
- Acronym
- Phase III
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT06819774
- Acronym / sponsor ID
- Phase III / NTP-XTLQ-I-Ⅲ
- Conditions
- Acute Urticaria
- Keywords
- Cetirizine hydrochloride injection, acute urticatia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Cetirizine Hydrochloride InjectionCetirizine hydrochloride injection；diphenhydramine hydrochloride injection simulator |
| Arm 2 | Experimental | Drug: Diphenhydramine Hydrochloride Injectiondiphenhydramine hydrochloride injection ；Cetirizine hydrochloride injection simulant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine Hydrochloride InjectionAlso: Simulant of Diphenhydramine Hydrochloride InjectionThe 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. | Drug | Arm 1 |
| Diphenhydramine Hydrochloride InjectionAlso: Simulant of Cetirizine Hydrochloride InjectionThe 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. | Drug | Arm 2 |
Primary outcome
Scoring of the severity of pruritus
Time frame: Two hours after the treatment was completed
Scoring of the severity of pruritus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetirizine Hydrochloride Injection and Diphenhydramine Hydrochloride Injection in people with Acute Urticaria, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring of the severity of pruritus (time frame: Two hours after the treatment was completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.