Recruiting
Phase 3

Doxepin

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT05115136

Conditions

Urticaria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Doxepin

Diphenhydramine

Study Details

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

Study ID

NCT05115136

Start date

May 23, 2022

Status verified date

May, 2022

Completion date

Jul 1, 2023

Anticipated

Primary completion date

Jan 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Doxepin

25mg PO one time

active comparator: Diphenhydramine

50mg PO one time

Interventions

Doxepin

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

Diphenhydramine

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

Primary outcome measure

  • Improvement of urticaria [ Time Frame: 1 hour after med administration, 2 hours after administration, and prior to discharge. ]
  • Improvement of urticaria [ Time Frame: 1 hour after med administration, 2 hours after administration, and prior to discharge ]

Central Contacts and Locations

Central contacts

David Andonian, MD

315-464-4363andoniad@upstate.edu

Locations

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Lauren Pacelli, BA

315-464-6201pacellil@upstate.edu

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2022-05-18.