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Using Doxepin for Urticaria

Sponsor
State University of New York - Upstate Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05115136
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
13.3
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 23, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvement of urticaria [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 SUNY Upstate Medical University Syracuse New York United States 13210

Sponsors and Collaborators

  • State University of New York - Upstate Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 10, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urticaria
Diphenhydramine
Promethazine
Doxepin

Study Results

No Results Posted as of May 18, 2022