Clinical trial

Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency

Name
11 221 02
Description
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.
Trial arms
Trial start
2012-02-01
Estimated PCD
2014-02-01
Trial end
2014-02-01
Status
Completed
Phase
Early phase I
Treatment
placebo
Xyzall 5mg during 5 days + placebo 40mg during 4 days
Arms:
placebo
prednisone
Xyzall 5mg during 5 days + prednisone 40mg during 4 days
Arms:
prednisone
Size
100
Primary endpoint
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
48 hours
Eligibility criteria
Inclusion Criteria: * adults * urticaria rash no more 24 h duration and no take treatment for urticaria Exclusion Criteria: * patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED, * severe infection * pregnancy * patients BPCO * diabetics * allergy corticosteroids * refusal to comply * participate an other study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-05-23

1 organization

2 drugs

1 indication

Indication
Urticaria