MedTrace Logo

Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria

NCT02935699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2019-11-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Acute Urticaria

Interventions

DRUG

Test Drug (JDP-205)

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

DRUG

Active Control (Diphenhydramine)

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

Sponsors & Collaborators

  • JDP Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • JIE DU, PH.D. · JDP Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935699 on ClinicalTrials.gov