Clinical trial NCT02935699: Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria
Official title: A Phase III, Multi-center, Double Blind, Randomized, Active Controlled Clinical Trial to Evaluate the Non-Inferiority Comparing Cetirizine Injection 10 mg to Diphenhydramine Injection, 50 mg, for the Treatment of Acute Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Urticaria
Lead sponsor: JDP Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a multi-center, parallel group, randomized, double-blind, active controlled, Phase III clinical trial of cetirizine injection 10 mg/mL versus diphenhydramine injection 50 mg/mL (Benadryl or generic equivalent) in approximately 256 subjects who either presented to Emergency Departments, hospitals, allergy clinics or Urgent Care Centers with acute urticaria, or developed acute urticaria following allergen challenge at an Allergy Clinic.

Patients signed an informed consent and were evaluated for eligibility for inclusion to treat. Eligible subjects were assessed for baseline characteristics, medical and surgical histories, concomitant medications and given a brief physical exam.

Subjects were then randomized, in a 1:1 ratio, to blindly receive either cetirizine 10 mg/mL injection or diphenhydramine 50 mg/mL injection.

Efficacy assessments included patient-rated severity of pruritus, physician assessments of extent of urticaria/erythema, and sedation score. Subjects remained in the treatment center for at least after the 1 hr assessment, after which they may have been discharged at the physician's discretion.

Safety was monitored through the reporting of adverse events for up to 28 days following treatments and by monitoring vital signs at planned intervals from admission into the treating facility until readiness for discharge. After 24 and 48 hrs after discharge, subjects were contacted by phone for follow-up questions regarding recurrence of symptoms, new symptoms, additional medication taken, side effects from medication taken after discharge, relapse requiring a return to treatment center, and return to normal activities.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients with a diagnosis of acute urticaria who need treatment with 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 Patient rated Pruritus Severity Score ≥ 1

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 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
5. Receipt of an H2 antagonist within the past 2 hours;
6. Receipt of doxepin within the past 2 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 4 hours to manage an acute allergic reaction;
8. Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
9. Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
10. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
11. Pregnancy or breastfeeding;
12. Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
13. 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;
14. Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
15. History of HIV or other known immunodeficiency;
16. Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
17. Inability to provide informed consent.
18. Patients on concomitant p-glycoprotein inhibitors

Primary outcomes:
measure: Change of Patient Rated Pruritus Score
timeFrame: 2 hr
Secondary outcomes:
measure: Number of Patients Who Needed to Return to Treatment Center
timeFrame: up to 24 hrs
measure: Time to Discharge
timeFrame: up to 24 hours
measure: Patient Sedation Scores
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Univ of Cincinnati Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: City Doc Urgent Care center
state: Texas
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: JDP Therapeutics, Inc.
name: JIE DU, PH.D.
role: STUDY_CHAIR
References:
citation: Abella BS, Berger WE, Blaiss MS, Stiell IG, Herres JP, Moellman JJ, Suner S, Kessler A, Klausner HA, Caterino JM, Du J. Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial. Ann Emerg Med. 2020 Oct;76(4):489-500. doi: 10.1016/j.annemergmed.2020.05.025. Epub 2020 Jul 9.