search
Back to results

Using Doxepin for Urticaria

Primary Purpose

Urticaria

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxepin
Diphenhydramine
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • SUNY Upstate Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doxepin

Diphenhydramine

Arm Description

25mg PO one time

50mg PO one time

Outcomes

Primary Outcome Measures

Improvement of urticaria
Improvement of urticaria based on pruritis score. Scale is from 1-5, lower the score the better.
Improvement of urticaria
Improvement of urticaria based percent of body area affected. Scale being utilized is the % of body area chart.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2021
Last Updated
May 17, 2022
Sponsor
State University of New York - Upstate Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05115136
Brief Title
Using Doxepin for Urticaria
Official Title
The Use of Doxepin for Urticaria in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Doxepin
Arm Type
Experimental
Arm Description
25mg PO one time
Arm Title
Diphenhydramine
Arm Type
Active Comparator
Arm Description
50mg PO one time
Intervention Type
Drug
Intervention Name(s)
Doxepin
Intervention Description
25mg dose of Doxepin will be administered one time, by mouth
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
50 mg dose of Diphenhydramine will be administered one time, by mouth
Primary Outcome Measure Information:
Title
Improvement of urticaria
Description
Improvement of urticaria based on pruritis score. Scale is from 1-5, lower the score the better.
Time Frame
1 hour after med administration, 2 hours after administration, and prior to discharge.
Title
Improvement of urticaria
Description
Improvement of urticaria based percent of body area affected. Scale being utilized is the % of body area chart.
Time Frame
1 hour after med administration, 2 hours after administration, and prior to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Andonian, MD
Phone
315-464-4363
Email
andoniad@upstate.edu
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Pacelli, BA
Phone
315-464-6201
Email
pacellil@upstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Doxepin for Urticaria

We'll reach out to this number within 24 hrs