Using Doxepin for Urticaria

• ClinicalTrials.gov Identifier: NCT05115136
• Recruitment Status: Recruiting
• First Posted: November 10, 2021
• Last Update Posted: May 18, 2022
• Sponsor: State University of New York - Upstate Medical University
• Information provided by (Responsible Party): David Andonian, State University of New York - Upstate Medical University

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
Urticaria	Drug: Doxepin; Drug: Diphenhydramine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: May 23, 2022
• Estimated Primary Completion Date: January 31, 2023
• Estimated Study Completion Date: July 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: David Andonian, MD; 315-464-4363; andoniad@upstate.edu

Locations

United States, New York

SUNY Upstate Medical University; Recruiting

Syracuse, New York, United States, 13210

Contact: Lauren Pacelli, BA 315-464-6201 pacellil@upstate.edu

Sponsors and Collaborators

State University of New York - Upstate Medical University

More Information

• 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: November 10, 2021
• Last Update Posted: May 18, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• 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; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Diphenhydramine; Promethazine; Doxepin; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; Anesthetics; Sensory System Agents; Peripheral Nervous System Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Antipruritics; Dermatologic Agents; Antidepressive Agents, Tricyclic; Antidepressive Agents