Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

Completed · Phase 3

Conditions studied: Acute Urticaria

In brief

This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.

Key facts

Study ID

NCT02935699

Run by

JDP Therapeutics, Inc.

People needed

262

Starts

2017-03-01

Expected to finish

2018-04-30

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;
• 18 years of age or older;
• Be willing and able to give informed consent;
• Patients with a Patient rated Pruritus Severity Score ≥ 1

You may not qualify if…

• Receipt of an investigational drug or device, within the past 30 days;
• Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
• Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
• Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
• Receipt of an H2 antagonist within the past 2 hours;
• Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties;
• Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction;
• Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
• Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
• Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
• Pregnancy or breastfeeding;
• Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
• Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
• Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
• History of HIV or other known immunodeficiency;
• Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
• Inability to provide informed consent.
• Patients on concomitant p-glycoprotein inhibitors

Where it is running

• Univ of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Einstein Medical Center — Philadelphia, Pennsylvania, United States
• City Doc Urgent Care center — Dallas, Texas, United States
• Ottawa Hospital — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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