Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria

Acute Urticaria Clinical Trial

Official title:

Multicenter Pilot Study to Assess the Feasibility of Conducting Phase III Trial Comparing IV Cetirizine Injection, 10 mg, to IV Diphenhydramine, 50 mg, for The Treatment of Acute Urticaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023164
• Other study ID #: ETTAU-02
• Secondary ID: CTN-P4-427
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2024
• Source: JDP Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. This study will be conducted in 33 patient who either present themselves to the hospital emergency department, allergy clinic or urgent care centers with acute urticaria or developed acute urticaria following a allergen challenge at an allergy clinic. Following informed consent, eligibility will be established, capturing baseline data including vitals, age, medical history, and medications taken prior to coming to the clinical study site. Following data collection, study subjects will be randomized in a 1:1 ratio to receive study drug of either cetirizine 10 mg IV or diphenhydramine, 50 mg IV. Baseline data including vital signs, the extent of urticaria and erythema, the severity of pruritus, and the level of sedation will be recorded prior to and at 1 hour and 2 hours post study drug administration, and at the time of "Readiness for Discharge". The actual time at which the investigator determines that the subject is ready for discharge (physically and mentally fit) from the study site will also be recorded. At these same time intervals, subjects will be asked to self-rate (recorded by study staff) severity of their pruritus and level of sedation (recorded by study staff). Twenty-four hours following discharge from the study site, study staff will call the subject to ask them a few short questions to follow-up on the treatment of their acute urticaria. All adverse and serious adverse events experienced by the subjects following informed consent, and all data captured will be recorded in the source documents and/or case report forms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Urticaria
• Urticaria

Intervention

Drug:
• JDP-205 Injection
Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
• Diphenhydramine
Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes

Locations

Country	Name	City	State
Canada	Glengarry Memorial Hospital, Independent Practice	Alexandria	Ontario
Canada	Del Carpio Independent Practice	Montréal	Quebec
Canada	Ottawa Hospital, Civic Campus	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
United States	University of Cincinnati, Department of Emergency Medicine	Cincinnati	Ohio
United States	OSU Hospitals, Department of Emergency Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
JDP Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of Urticaria/Erythema Score (Physician Assessment)	Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart).; Extent of Urticaria/Erythema Score is the average of the 2 scores: Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage; Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red)	Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)
Primary	Physician Pruritus Severity Score	Physician Pruritus Severity Score based on patient expression of severity of itchiness.; 0= none; 1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Primary	Patient Pruritis Severity Score	Patient Pruritis Severity Score based on severity of itching at time of assessment.; How severly are your hives itching at the moment? 0 = none; 1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate	Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Primary	Composite Acute Urticaria Score Change From Baseline	A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
Secondary	Sedation Scores and Time to Readiness for Discharge	Time from study drug injection to time to readiness for discharge based on composite sedation score at readiness for discharge consist of Physician Sedation Score and Patient Sedation Score; Physician Sedation Score; Score ranged from 0 to 4 (0=min, 4=max); 0 = None (Patient is completely alert. Does not look tired at all), 1 = Mild (Patient sitting/lying comfortably, and looks tired), 2 = Moderate (Drowsy, with occasional eyes closing), 3 = Severe (Asleep, with eyes closed but responds to minor motor stimulation), 4 = Extremely Severe (Asleep; does not respond to minor motor stimulation); Patient Sedation Score; Score ranged from 0 to 4 (0=min, 4=max); 0 = None (Not drowsy at all), 1 = Mild (Slightly drowsy), 2 = Moderate (Quite drowsy), 3 = Severe (Extremely drowsy), 4 = Extremely Severe (Asleep, cannot self-rate); Higher the sedation score = worse outcome; A composite sedation score which is the sum of the two parameters.	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.
Secondary	Percentage of Patients Requiring Additional Medication	Percentage of Patients Requiring Additional Medication (Rescue Medication)	Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
Secondary	Sedation Scores and Time to Readiness for Discharge HH:MM	Time from study drug injection to time to readiness for discharge based on Physician and Patient Sedation Scores; Physician Sedation Score: 0 = None; 1 = Mild 2 = Moderate 3= Severe 4 = Extremely Severe Patient Sedation Score 0= None; 1- Mild 2 = Moderate 3= Severe 4 = Extremely Severe Higher scores = worse outcome	Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.