Overview
Sponsor-declared trial summary
Adults patients with isolated acute urticaria presenting to the emergency department
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
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 21 Sep 2019 → 17 Sep 2025
- Decision date (initial)
- 2024-08-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515308-38-00
- EudraCT number
- 2018-002308-15
- ClinicalTrials.gov
- NCT03545464
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
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
Conditions and MedDRA coding
Adults patients with isolated acute urticaria presenting to the emergency department
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10001106 | Acute urticaria | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age > 18 years
- Acute urticaria with angioedema without laryngeal edema
- Obtain patient’s consent
- Social security affiliation
Exclusion criteria 21
- 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: 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 7-Days Urticaria Activity Score (UAS 7) at day 7
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CORTANCYL 20 mg, comprimé sécable
PRD9995018 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 34009 574 899 6 0
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Coordinating Investigator
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Coordinating Investigator
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 240 | 17 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2019-09-21 | 2025-09-17 | 2019-09-21 | 2025-02-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515308-38-00 | 5-0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1-1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CORTANCYL 20 mg | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | France | Acceptable 2024-08-12
|
2024-08-13 |