CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
JDP-205 Injection +1 moredrug
Likely dose
JDP-205 Injection 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02023164
NCT02023164Phase 3Completed
CompareCT.gov

Multicenter Pilot Study to Assess the Feasibility of Conducting Phase III Trial Comparing IV Cetirizine Injection, 10 mg, to IV Diphenhydramine, 50 mg, for The Treatment of Acute Urticaria

JDP Therapeutics, Inc.·interventional·Posted Dec 30, 2013·Updated Feb 9, 2024

In Brief

A Phase 3 clinical trial evaluating JDP-205 Injection and Diphenhydramine for Acute Urticaria. Completed, enrolled 36 participants across 6 sites in 2 countries.

Detailed Summary

This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Urticaria
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 30, 2013
Enrollment StartJul 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.5 years ago

Interventions

JDP-205 Injectiondrug

Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Diphenhydraminedrug

Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes