Using Doxepin for Urticaria
Primary Purpose
Urticaria
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxepin
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria
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)
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
NCT ID
NCT05115136
First Posted
October 5, 2021
Last Updated
May 17, 2022
Sponsor
State University of New York - Upstate Medical University
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
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Using Doxepin for Urticaria
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