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Trial record 78 of 448 for:    diphenhydramine

Multicenter Pilot Phase III Clinical Trials of JDP-205 iv Injection for the Treatment of Acute Urticaria Associated With an Acute Allergic Reaction.

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. Identifier: NCT02023164
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
JDP Therapeutics, Inc.

Brief Summary:
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 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.

Condition or disease Intervention/treatment Phase
Acute Urticaria Drug: JDP-205 Injection Drug: Diphenhydramine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: Test Drug
10 mg/mL, 1 mL
Drug: JDP-205 Injection
Active Comparator: Control
50 mg/mL, 1 mL
Drug: Diphenhydramine

Primary Outcome Measures :
  1. Change of Extent of Urticaria symptom score [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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

Patients are eligible to be included in the study only if they meet all of the following criteria:

  1. 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;
  2. 18 years of age or older;
  3. Be willing and able to give informed consent;
  4. Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the investigator);
  5. Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the investigator).

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 4 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
  5. Receipt of an H2 antagonist within the past 12 hours;
  6. Receipt of doxepin within the past 48 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 48 hours to manage an acute allergic reaction;
  8. Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;
  9. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
  10. Pregnancy or breastfeeding;
  11. Patients who require epinephrine immediately to manage their acute allergic symptoms;
  12. Patients who have an acute reaction to medication they are taking (e.g. antibiotics, ACE inhibitors, NSAIDs) and who cannot stop the medication;
  13. 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;
  14. Urticaria not associated with an acute allergic reaction;
  15. Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
  16. History of HIV or other known immunodeficiency;
  17. Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
  18. Inability to provide informed consent.

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 identifier (NCT number): NCT02023164

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Canada, Alberta
Foothill Medical Center
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
JDP Therapeutics, Inc.

Additional Information:
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Responsible Party: JDP Therapeutics, Inc. Identifier: NCT02023164     History of Changes
Other Study ID Numbers: ETTAU-02
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Dermatologic Agents