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Using Doxepin for Urticaria

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ClinicalTrials.gov Identifier: NCT05115136
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
David Andonian, State University of New York - Upstate Medical University

Brief Summary:
Isolated urticaria in the emergency department is widely treated by physicians with histamine blocking agents such as diphenhydramine, cetirizine, and cimetidine. Doxepin is a tricyclic antidepressant that has been shown to have much higher concentrations of histamine blocking activity and therefore may be useful in treating urticaria. The purpose of this study is to compare the effectiveness of using doxepin verses a traditional medication, diphenhydramine (Benadryl), in the treatment of isolated urticaria in the emergency department.

Condition or disease Intervention/treatment Phase
Urticaria Drug: Doxepin Drug: Diphenhydramine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Use of Doxepin for Urticaria in the Emergency Department
Estimated Study Start Date : May 23, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 1, 2023

Arm Intervention/treatment
Experimental: Doxepin
25mg PO one time
Drug: Doxepin
25mg dose of Doxepin will be administered one time, by mouth

Active Comparator: Diphenhydramine
50mg PO one time
Drug: Diphenhydramine
50 mg dose of Diphenhydramine will be administered one time, by mouth

Primary Outcome Measures :
  1. Improvement of urticaria [ Time Frame: 1 hour after med administration, 2 hours after administration, and prior to discharge. ]
    Improvement of urticaria based on pruritis score. Scale is from 1-5, lower the score the better.

  2. Improvement of urticaria [ Time Frame: 1 hour after med administration, 2 hours after administration, and prior to discharge ]
    Improvement of urticaria based percent of body area affected. Scale being utilized is the % of body area chart.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between 18-65 years of age
  • Presenting to Upstate Adult Emergency Department at either the Downtown or Community campuses.
  • Diagnosed with isolated/acute urticaria
  • Requires treatment with antihistamines to alleviate symptoms

Exclusion Criteria:

  • Pregnant women
  • Prisoners
  • Patients with altered mental status/have impaired decision-making capacity.
  • Presenting with symptoms suggesting life threatening illness or anaphylaxis.
  • Patients who have received any antihistamine (H1 antagonist) within the past 2 hours via any route of administration.
  • Patients who have received an H2 antagonist within the past 2 hours.
  • Patient received steroids by any route within the past 4 hours.
  • Patient received epinephrine within the past 20 minutes.
  • Patients currently taking concomitant p-glycoprotein inhibitors.
  • Patients on any of the following CYP2D6 inhibitors: Bupropion, Fluoxetine, Paroxetine, Quinidine, Tipranavir.
  • Patients with a history of serotonin syndrome.
  • Patients currently taking another tricyclic antidepressant, selective serotonin reuptake inhibitor, and/or serotonin-norepinephrine reuptake inhibitor.
  • Patients who have a condition where an antihistamine may be contraindicated.
  • Patients with a contraindication to anticholinergic medications.
  • History of adverse effects to tricyclic antidepressants or antihistamines.
  • Patient who, based on their medical history or in the opinion of the clinician, have chronic urticaria, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response.
  • Patients taking antileukotriene compounds (montelukast), calcineurin inhibitors (tacrolimus) or anti-serotonin agents (cyproheptadine)

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): NCT05115136

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Contact: David Andonian, MD 315-464-4363 andoniad@upstate.edu

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United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Lauren Pacelli, BA    315-464-6201    pacellil@upstate.edu   
Sponsors and Collaborators
State University of New York - Upstate Medical University
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Responsible Party: David Andonian, Principal Investigator, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT05115136    
Other Study ID Numbers: 1576028
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
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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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Sleep Aids, Pharmaceutical
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
Antidepressive Agents, Tricyclic
Antidepressive Agents