NCT02565680

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

July 22, 2014

Last Update Submit

May 22, 2023

Conditions

Acute Urticaria

Keywords

acute urticariaglucocorticoidsantihistaminesprurititch scorerash

Outcome Measures

Primary Outcomes (1)

  • To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours

    To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score

    48 hours

Secondary Outcomes (5)

  • Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace

    21 days

  • The necessary time to decrease pruritus and rash

    21 days

  • The frequency of side-effects in either treatment group in 21 days

    21 days

  • Recidive of urticaria

    21 days

  • The observance treatment

    21 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days

Drug: placebo

prednisone

EXPERIMENTAL

tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days

Drug: prednisone

Interventions

placeboDRUG

Xyzall 5mg during 5 days + placebo 40mg during 4 days

placebo
prednisoneDRUG

Xyzall 5mg during 5 days + prednisone 40mg during 4 days

prednisone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • urticaria rash no more 24 h duration and no take treatment for urticaria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.

    PMID: 28476259RESULT

MeSH Terms

Conditions

Exanthema

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Caroline Barniol, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

October 1, 2015

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

FR(1)