Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria
Condition: Acute Urticaria
MeSH terms: Urticaria
Intervention: JDP-205 Injection; Diphenhydramine
Intervention description: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes; Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
Intervention MeSH terms: Diphenhydramine; Promethazine; Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: urticaria; allergic reaction; cetirizine; JDP-205

Summary:

      This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical
      study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl
      or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment
      in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.
    

Eligibility criteria:

        Patients are eligible to be included in the study only if they meet all of the following
        criteria:

        Inclusion Criteria:

          -  Male or female patients with a diagnosis of acute urticaria associated with an acute
             allergic reaction to a known (e.g. food, medication, insect bites) or unknown allergen
             who need treatment with an injectable antihistamine to alleviate their symptoms;

          -  18 years of age or older;

          -  Be willing and able to give informed consent;

          -  Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the
             investigator);

          -  Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the
             investigator).

        Exclusion Criteria:

          -  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 4 hours regardless of the
             route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine,
             levocetirizine, desloratadine;

          -  Receipt of an H2 antagonist within the past 12 hours;

          -  Receipt of doxepin within the past 48 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
             48 hours to manage an acute allergic reaction;

          -  Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;

          -  Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;

          -  Pregnancy or breastfeeding;

          -  Patients who require epinephrine immediately to manage their acute allergic symptoms;

          -  Patients who have an acute reaction to medication they are taking (e.g. antibiotics,
             ACE inhibitors, NSAIDs) and who cannot stop the medication;

          -  Patients who, based on their medical history or in the opinion of the investigator,
             have chronic idiopathic urticaria, hereditary angioedema, urticaria refractory to
             antihistamines, or dermatological disease that interferes with evaluation of a
             therapeutic response;

          -  Urticaria not associated with an acute allergic reaction;

          -  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.