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Antihistamine

Doxepin for Hives

Phase 3
Waitlist Available
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after med administration, 2 hours after administration, and prior to discharge
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares the effectiveness of doxepin versus diphenhydramine in treating isolated urticaria in the emergency department.

Eligible Conditions
  • Hives

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after med administration, 2 hours after administration, and prior to discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after med administration, 2 hours after administration, and prior to discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement of urticaria

Side effects data

From 2010 Phase 4 trial • 44 Patients • NCT00465972
13%
dry mouth
4%
sedation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Temazepam

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DoxepinExperimental Treatment1 Intervention
25mg PO one time
Group II: DiphenhydramineActive Control1 Intervention
50mg PO one time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxepin
2018
Completed Phase 4
~560

Find a Location

Who is running the clinical trial?

State University of New York - Upstate Medical UniversityLead Sponsor
174 Previous Clinical Trials
27,341 Total Patients Enrolled
~47 spots leftby Nov 2025
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