COrticosteroids in acUte uRticAria in emerGency dEpartment

Trial Information
Who is this study for? Patients with acute urticaria
What treatments are being studied? Levocetirizine; Cortancyl+Levocetirizine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
Summary

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

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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

Where is this trial taking place?
Other Locations
France
Hospital Louis MOURIER
Recruiting
Colombes
Who do I contact about this trial?
Primary
Nicolas JAVAUD, M.D,Ph.D
nicolas.javaud@aphp.fr
+33 1 47 60 64 42
Backup
Fréderic ADNET, M.D,Ph.D
frederic.adnet@aphp.fr
+33 1 48 96 44 08
When is this trial taking place?
Start Date: September 21, 2019
Estimated Completion Date: March 21, 2022
How many participants will be in this trial?
Target number of participants: 240
What treatment is being studied in this trial?
Experimental: Antihistamines + placebo of cortancyl
- In emergency department : Levocetirizine 5 mg orally. Renewable once if persistence of hives at 30 minutes.~Placebo of Cortancyl : 1mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally~- At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14).~Placebo of Cortancyl 20 mg x 2 tablets = 40mg once per day for 3 days orally
Active Comparator: Association of antihistamines and cortancyl
- In emergency department : Levocetirizine 5 mg orally Renewable once if persistence of hives at 30 minutes.~Cortancyl: 1 mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally.~- At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14).~Cortancyl : 20 mg x 2 tablets = 40 mg per day for 3 days orally
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov