Adults patients with isolated acute urticaria presenting to the emergency department MedDRA version: 20.0 Level: LLT Classification code 10001106 Term: Acute urticaria System Organ Class: 100000004858
Conditions
Interventions
Trade Name: CORTANCYL
Product Name: CORTANCYL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria Acute urticaria with angioedema without laryngeal edema Obtain patient’s consent Social security affiliation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding Acute hives with anaphylaxis Bradykinin angioedema Angioedema without urticaria (hives) Laryngeal edema with urticaria (hives) Corticosteroid administration in the previous 5 days visiting the emergency department Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED Other treatment for urticaria : omalizumab, montelukast, ciclosporine A Chronic urticaria before acute urticaria diagnosis Atopic dermatitis Eczema Bullous pemphigoid Acute exanthematous pustulosis Diabetes mellitus Gastrointestinal ulcer Refusal to participate Known allergy to the study drugs or formulation ingredients Hypersensitivity to lactose Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%. Hypersensitivity to active substance, to cetirizine, to hydroxyzine and to pipérazine and excipients Contre-indication to corticotherapy: oAny live vaccine oPsychotic states still uncontrolled by treatment limiting the participant's compliance with the research oSome viruses in evolution (including hepatitis, herpes, chicken pox, shingles). oAny infectious condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparaison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments;Secondary Objective: To compare the number of urticaria recurrences at day 7, to compare the number of transition to chronic urticaria, to compare the morbidity, to compare the number of patients with angioedema, to compare the quality of life;Primary end point(s): 7-Days Urticaria Activity Score (UAS 7);Timepoint(s) of evaluation of this end point: at day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): recurrences of heaves and/or itch at day 7, occurrence of spontaneous wheals and/or itch for > 6 weeks, the reduction of morbidity is assess by new emergency visits for acute urticaria recurrences, Dermatology Life Quality Index (DLQI), Cu-Q2oL;Timepoint(s) of evaluation of this end point: at day 7, and after 6 weeks | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed