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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02935699
Recruitment Status : Completed
First Posted : October 17, 2016
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
JDP Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Urticaria Drug: Test Drug (JDP-205) Drug: Active Control (Diphenhydramine) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018


Arm Intervention/treatment
Experimental: Test Drug
JDP-205 Injection, 10 mg/mL, 1 mL
Drug: Test Drug (JDP-205)
Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
Other Name: QUZYTTIR

Active Comparator: Control
Diphenhydramine Injection, 50 mg/mL, 1 mL
Drug: Active Control (Diphenhydramine)
Diphenhydramine Injection, 50 mg/mL;a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
Other Name: Benadryl




Primary Outcome Measures :
  1. Change of Patient Rated Pruritus Score [ Time Frame: 2 hr ]

    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

    1. = mild (minimal awareness, easily tolerated)
    2. = moderate (definite awareness, quite bothersome)
    3. = severe (difficult to tolerate)


Secondary Outcome Measures :
  1. Number of Patients Who Needed to Return to Treatment Center [ Time Frame: up to 24 hrs ]
    Number of patients who needed to return to treatment center approximately 24 hours after discharge

  2. Time to Discharge [ Time Frame: up to 24 hours ]
    Time spent (hours) at the treatment center

  3. Patient Sedation Scores [ Time Frame: 2 hours ]

    Patient Sedation Score at 2 hours

    Ask the patient "How drowsy do you feel at the moment?" 0 = None (Not drowsy at all)

    1. = Mild (Slightly drowsy)
    2. = Moderate (Quite drowsy)
    3. = Severe (Extremely drowsy)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935699


Locations
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United States, Ohio
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
City Doc Urgent Care center
Dallas, Texas, United States, 75209
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
JDP Therapeutics, Inc.
Investigators
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Study Chair: JIE DU, PH.D. JDP Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by JDP Therapeutics, Inc.:
Study Protocol  [PDF] April 10, 2017
Statistical Analysis Plan  [PDF] May 8, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JDP Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02935699    
Other Study ID Numbers: ETTAU-03
First Posted: October 17, 2016    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents