Using Doxepin for Urticaria

Phase 3

• Conditions: Urticaria
• Interventions: Drug: Diphenhydramine; Drug: Doxepin

• Registration Number: NCT05115136
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Study Start: 2022-05-23
• Primary Completion: 2023-01-31
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diphenhydramine	Diphenhydramine	50mg PO one time
Doxepin	Doxepin	25mg PO one time

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States