2024-515308-38-00招募中3 期
COURAGE - Corticosteroid in acute urticaria in emergency department
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris5 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年8月13日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- 7-Days Urticaria Activity Score (UAS 7) at day 7
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Acute urticaria with angioedema without laryngeal edema
- •Obtain patient’s consent
- •Social security affiliation
排除标准
- •Pregnancy or breastfeeding
- •Atopic dermatitis
- •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%
- •Acute hives with anaphylaxis
- •Hypersensitivity to active substance, to cetirizine, to hydroxyzine and to pipérazine and excipients
- •Contre-indication to corticotherapy: o Any live vaccine o Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research o Some viruses in evolution (including hepatitis, herpes, chicken pox, shingles). o Any infectious condition
- •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
结局指标
主要结局
7-Days Urticaria Activity Score (UAS 7) at day 7
7-Days Urticaria Activity Score (UAS 7) at day 7
次要结局
未报告次要终点
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (5)
Loading locations...
相似试验
招募中
1 期
Corticosteroid in acute urticaria in emergency departmentAdults patients with isolated acute urticaria presenting to the emergency departmentMedDRA version: 21.1Level: LLTClassification code: 10001106Term: Acute urticaria Class: 10040785CTIS2024-515308-38-00Assistance Publique Hopitaux De Paris240
已完成
3 期
COrticosteroids in acUte uRticAria in emerGency dEpartmentAngiœdemaUrticariaNCT03545464Assistance Publique - Hôpitaux de Paris137
进行中（未招募）
1 期
A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shockSeptic ShockEUCTR2012-003158-10-IEThe George Institute for Global Health3,800
进行中（未招募）
1 期
A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shockSeptic ShockEUCTR2012-003158-10-DKThe George Institute for Global Health3,800
进行中（未招募）
不适用
A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shockMedDRA version: 16.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsSeptic ShockEUCTR2012-003158-10-GBThe George Institute for Global Health3,800