Higher-dose cetirizine for acute hives in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group study comparing standard-dose cetirizine (10 mg once daily) with a higher-dose regimen (40 mg per day) for 7 days in adults with acute urticaria. Participants will record daily itch and hive severity, have visits on Days 3, 7, and Week 6, and undergo blood tests to assess liver and kidney function. The trial uses blinded outcome assessment to reduce bias and seeks to determine whether the higher dose provides faster or greater symptom relief without additional safety risks. Results could inform safer, more effective use of antihistamines and reduce reliance on corticosteroids in acute urticaria care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 to 60 years
* Clinical diagnosis of acute urticaria made by a physician
* Onset of new wheals within the past 24 hours
* Able and willing to comply with study procedures, complete symptom diaries, and attend follow-up visits
* Provides written informed consent prior to participation

Exclusion Criteria:

* Use of systemic corticosteroids within the past 5 days
* Use of immunosuppressive medications within the past 5 days
* Clinical signs of anaphylaxis, including respiratory distress, hypotension, abdominal pain, or acute laryngeal swelling
* Presence of angioedema without wheals
* Known diagnosis of chronic urticaria
* Known severe renal impairment (creatinine clearance \<10 mL/min), heart failure (ejection fraction \<40%), or hepatic failure
* Other skin conditions that may interfere with assessment (e.g., atopic dermatitis, eczema, bullous pemphigoid, AGEP)
* Use of ACE inhibitors or ARBs within the past 5 days
* Known allergy or hypersensitivity to cetirizine or components of the study medication
* Pregnancy or breastfeeding
* Known diabetes mellitus
* History of gastrointestinal ulcer disease
* Any condition that, in the investigator's judgment, would interfere with study participation or safety
* Declines to provide informed consent

Where it's running

• University of Phayao Hospital
  Phayao, Mueang, Thailand Recruiting

Study contacts

• Principal investigator: Wasuchon Chaichan — School of Medicine, University of Phayao
• Study coordinator: Wasuchon Chaichan, MD
• Email: wasuchon.ch@gmail.com
• Phone: +6654466666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cetirizine injection for treating acute urticaria

  This study is testing if an injection of cetirizine can help adults with acute urticaria feel better and itch less compared to a standard treatment.

  Recruiting Phase 3 Shandong New Time Pharmaceutical Co., LTD · Beijing, Beijing Municipality · NCT06819774

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• BBT001 in adults with chronic spontaneous urticaria

  This trial tests whether BBT001 given by IV is safe and can help reduce urticaria in adults who have chronic spontaneous hives.

  Recruiting Phase 1/2 Bambusa Therapeutics · Wuhu, Anhui and 9 other locations · NCT07717905

• Remibrutinib in real-world care for Chronic Spontaneous Urticaria in Germany

  This study looks at how well and how safely remibrutinib works for adults with chronic spontaneous urticaria in real clinical practice after doctors decide to switch or escalate treatment.

  Recruiting Novartis · Düren · NCT07642557

• Testing single and multiple oral doses of EDP-978 in healthy adults

  This study will test how safe and tolerable single and multiple oral doses of EDP-978 are in healthy adults and will measure how the body absorbs and responds to the drug.

  Recruiting Phase 1 Enanta Pharmaceuticals, Inc · San Antonio, Texas · NCT07540910

• Remibrutinib for adults with chronic spontaneous urticaria in routine care

  This prospective US study will see if remibrutinib helps adults with chronic spontaneous urticaria in real-world clinical practice using patient-reported outcome questionnaires.

  Recruiting Novartis · East Hanover, New Jersey · NCT07408219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.