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Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

Primary Purpose

Acute Urticaria

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Test Drug (JDP-205)

Active Control (Diphenhydramine)

About this trial

This is an interventional treatment trial for Acute Urticaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;
18 years of age or older;
Be willing and able to give informed consent;
Patients with a Patient rated Pruritus Severity Score ≥ 1

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 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
Receipt of an H2 antagonist within the past 2 hours;
Receipt of doxepin within the past 2 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 4 hours to manage an acute allergic reaction;
Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
Pregnancy or breastfeeding;
Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
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;
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.
Patients on concomitant p-glycoprotein inhibitors

Sites / Locations

Univ of Cincinnati Medical Center
Einstein Medical Center
City Doc Urgent Care center
Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Drug

Control

Arm Description

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

Diphenhydramine Injection, 50 mg/mL, 1 mL

Outcomes

Primary Outcome Measures

Change of Patient Rated Pruritus Score

Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline) Patient Pruritus Severity Score Ask the patient "How severely are your hives itching at the moment?" 0 = none = mild (minimal awareness, easily tolerated) = moderate (definite awareness, quite bothersome) = severe (difficult to tolerate)

Secondary Outcome Measures

Number of Patients Who Needed to Return to Treatment Center

Number of patients who needed to return to treatment center approximately 24 hours after discharge

Time to Discharge

Time spent (hours) at the treatment center

Patient Sedation Scores

Patient Sedation Score at 2 hours Ask the patient "How drowsy do you feel at the moment?" 0 = None (Not drowsy at all) = Mild (Slightly drowsy) = Moderate (Quite drowsy) = Severe (Extremely drowsy)

Full Information

NCT ID

NCT02935699

First Posted

October 14, 2016

Last Updated

November 9, 2019

Sponsor

JDP Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02935699

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JDP Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Urticaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Drug

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Diphenhydramine Injection, 50 mg/mL, 1 mL

Intervention Type

Drug

Intervention Name(s)

Test Drug (JDP-205)

Other Intervention Name(s)

QUZYTTIR

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Active Control (Diphenhydramine)

Other Intervention Name(s)

Benadryl

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of Patient Rated Pruritus Score

Description

Time Frame

2 hr

Secondary Outcome Measure Information:

Title

Number of Patients Who Needed to Return to Treatment Center

Description

Number of patients who needed to return to treatment center approximately 24 hours after discharge

Time Frame

up to 24 hrs

Title

Time to Discharge

Description

Time spent (hours) at the treatment center

Time Frame

up to 24 hours

Title

Patient Sedation Scores

Description

Patient Sedation Score at 2 hours Ask the patient "How drowsy do you feel at the moment?" 0 = None (Not drowsy at all) = Mild (Slightly drowsy) = Moderate (Quite drowsy) = Severe (Extremely drowsy)

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms; 18 years of age or older; Be willing and able to give informed consent; Patients with a Patient rated Pruritus Severity Score ≥ 1 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 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine; Receipt of an H2 antagonist within the past 2 hours; Receipt of doxepin within the past 2 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 4 hours to manage an acute allergic reaction; Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes; Anaphylaxis prior to the acute anaphylactic symptoms having been treated. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine; Pregnancy or breastfeeding; Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication; 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; 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. Patients on concomitant p-glycoprotein inhibitors

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JIE DU, PH.D.

Organizational Affiliation

JDP Therapeutics, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Univ of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Einstein Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

City Doc Urgent Care center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75209

Country

United States

Facility Name

Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32653333

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.

Results Reference

derived

Links:

URL

http://jdptherapeutics.com

Description

Sponsor website

Learn more about this trial

Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

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