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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
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.
Details
| Lead sponsor | JDP Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2013-07 |
| Completion | 2014-12 |
Conditions
- Acute Urticaria
Interventions
- JDP-205 Injection
- Diphenhydramine
Primary outcomes
- Extent of Urticaria/Erythema Score (Physician Assessment) — Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)
Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart). Extent of Urticaria/Erythema Score is the average of the 2 scores: 1. Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage 2. Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red) - Physician Pruritus Severity Score — Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Physician Pruritus Severity Score based on patient expression of severity of itchiness. 0= none 1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously - Patient Pruritis Severity Score — Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Patient Pruritis Severity Score based on severity of itching at time of assessment. How severly are your hives itching at the moment? 0 = none 1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate - Composite Acute Urticaria Score Change From Baseline — Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.
Countries
United States, Canada