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

NCT ID: NCT02023164

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Acute Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test Drug

JDP-205 Injection, 10 mg/mL, 1 mL

Group Type: EXPERIMENTAL

JDP-205 Injection

Intervention Type: DRUG

Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Control

Diphenhydramine Injection, 50 mg/mL, 1 mL

Group Type: ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type: DRUG

Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Interventions

JDP-205 Injection

Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Intervention Type: DRUG

Diphenhydramine

Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Intervention Type: DRUG

Other Intervention Names

Cetirizine; Quzyttir; Benadryl; DPH

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JDP Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janine North, B.S.

Role: STUDY_DIRECTOR

TerSera Therapeutics LLC

Locations

University of Cincinnati, Department of Emergency Medicine

Cincinnati, Ohio, United States

OSU Hospitals, Department of Emergency Medicine

Columbus, Ohio, United States

Glengarry Memorial Hospital, Independent Practice

Alexandria, Ontario, Canada

Ottawa Hospital, Civic Campus

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Del Carpio Independent Practice

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

CTN-P4-427

Identifier Type: OTHER

Identifier Source: secondary_id

ETTAU-02

Identifier Type: -

Identifier Source: org_study_id