Using Doxepin for Urticaria

NCT05115136 | Unknown Phase 3 FDA Drug

• 1 other identifier: 1576028
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Urticaria

Outcome Measures

Primary Outcomes (2)

• Improvement of urticaria

  Improvement of urticaria based on pruritis score. Scale is from 1-5, lower the score the better.

  1 hour after med administration, 2 hours after administration, and prior to discharge.

• Improvement of urticaria

  Improvement of urticaria based percent of body area affected. Scale being utilized is the % of body area chart.

  1 hour after med administration, 2 hours after administration, and prior to discharge

Study Arms (2)

Doxepin

EXPERIMENTAL

25mg PO one time

Drug: Doxepin

Diphenhydramine

ACTIVE COMPARATOR

50mg PO one time

Drug: Diphenhydramine

Interventions

Doxepin DRUG

25mg dose of Doxepin will be administered one time, by mouth

Doxepin

Diphenhydramine DRUG

50 mg dose of Diphenhydramine will be administered one time, by mouth

Diphenhydramine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

MeSH Terms

Conditions

Urticaria

Interventions

Doxepin; Diphenhydramine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oxepins; Ethers, Cyclic; Ethers; Organic Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

David Andonian, MD

CONTACT

315-464-4363; andoniad@upstate.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 10, 2021
• Study Start: May 23, 2022
• Primary Completion: January 31, 2023
• Study Completion: July 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)