Multicenter Pilot Phase III Clinical Trials of JDP-205 iv Injection for the Treatment of Acute Urticaria Associated With an Acute Allergic Reaction.
Information source: JDP Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Urticaria
Intervention: JDP-205 Injection (Drug); Diphenhydramine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: JDP Therapeutics, Inc.
Summary
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical
study of JDP-205 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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change of Extent of Urticaria symptom score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Patients are eligible to be included in the study only if they meet all of the following
criteria:
1. 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;
2. 18 years of age or older;
3. Be willing and able to give informed consent;
4. Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the
investigator);
5. Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the
investigator).
Exclusion Criteria:
1. Receipt of an investigational drug or device, within the past 30 days;
2. Patients in whom an antihistamine may be contraindicated (e. g. narrow angle glaucoma,
symptomatic prostatic hypertrophy);
3. Patients who, in the opinion of the investigator, may not tolerate an IV injection of
diphenhydramine 50 mg, or cetirizine 10 mg;
4. 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;
5. Receipt of an H2 antagonist within the past 12 hours;
6. Receipt of doxepin within the past 48 hours; doxepin is an antidepressant, but it
also has antihistamine properties;
7. Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past
48 hours to manage an acute allergic reaction;
8. Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;
9. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
10. Pregnancy or breastfeeding;
11. Patients who require epinephrine immediately to manage their acute allergic symptoms;
12. Patients who have an acute reaction to medication they are taking (e. g. antibiotics,
ACE inhibitors, NSAIDs) and who cannot stop the medication;
13. 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;
14. Urticaria not associated with an acute allergic reaction;
15. Any condition that in the view of the investigator makes the subject unsuitable for
enrollment in this study;
16. History of HIV or other known immunodeficiency;
17. Major medical or psychiatric illness, other than acute urticaria, at the time of
presentation;
18. Inability to provide informed consent.
Locations and Contacts
Foothill Medical Center, Calgary, Alberta T2N 2T9, Canada
Additional Information
Starting date: July 2013
Last updated: April 3, 2015
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