NCT02935699

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: JDP Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multi-center, parallel group, randomized, double-blind, active controlled, Phase III clinical trial of cetirizine injection 10 mg/mL versus diphenhydramine injection 50 mg/mL (Benadryl or generic equivalent) in approximately 256 subjects who either presented to Emergency Departments, hospitals, allergy clinics or Urgent Care Centers with acute urticaria, or developed acute urticaria following allergen challenge at an Allergy Clinic. Patients signed an informed consent and were evaluated for eligibility for inclusion to treat. Eligible subjects were assessed for baseline characteristics, medical and surgical histories, concomitant medications and given a brief physical exam. Subjects were then randomized, in a 1:1 ratio, to blindly receive either cetirizine 10 mg/mL injection or diphenhydramine 50 mg/mL injection. Efficacy assessments included patient-rated severity of pruritus, physician assessments of extent of urticaria/erythema, and sedation score. Subjects remained in the treatment center for at least after the 1 hr assessment, after which they may have been discharged at the physician's discretion. Safety was monitored through the reporting of adverse events for up to 28 days following treatments and by monitoring vital signs at planned intervals from admission into the treating facility until readiness for discharge. After 24 and 48 hrs after discharge, subjects were contacted by phone for follow-up questions regarding recurrence of symptoms, new symptoms, additional medication taken, side effects from medication taken after discharge, relapse requiring a return to treatment center, and return to normal activities.

Conditions

• Acute Urticaria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2016-10-17
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study