CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 262 enrolled
Drug / intervention
Test Drug (JDP-205) +1 moredrug
Likely dose
Test Drug (JDP-205) 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/NCT02935699
NCT02935699Phase 3Completed
CompareCT.gov

A Phase III, Multi-center, Double Blind, Randomized, Active Controlled Clinical Trial to Evaluate the Non-Inferiority Comparing Cetirizine Injection 10 mg to Diphenhydramine Injection, 50 mg, for the Treatment of Acute Urticaria

JDP Therapeutics, Inc.·interventional·Posted Oct 17, 2016·Updated Nov 27, 2019

In Brief

A Phase 3 clinical trial evaluating Test Drug (JDP-205) and Active Control (Diphenhydramine) for Acute Urticaria. Completed, enrolled 262 participants across 4 sites in 2 countries.

Detailed Summary

This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.

Study Details

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

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 17, 2016
Enrollment StartMar 1, 2017
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.7 years ago

Interventions

Test Drug (JDP-205)drug

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

Active Control (Diphenhydramine)drug

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