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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284426
Other study ID # 374/2551(EC3)
Secondary ID
Status Completed
Phase N/A
First received January 20, 2011
Last updated December 30, 2015
Start date March 2003
Est. completion date March 2009

Study information

Verified date December 2015
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine the natural history of chronic urticaria in children and to identify the predictors for chronic urticaria remission.


Description:

A Prospective cohort study of 92 children who were diagnosed with chronic urticaria to investigate the natural course of chronic urticaria and to identify predictors of disease remission.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 15 Years
Eligibility Inclusion Criteria:

- Children 4-15 years of age with the diagnosis of chronic urticaria who were attending the pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, from March 2003 to March 2009.

Exclusion Criteria:

- Children who had isolated physical urticaria, inability to be followed up, pregnancy, underlying diseases such as cardiovascular, hepatobiliary, and renal diseases.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Chansakulporn S, Pongpreuksa S, Sangacharoenkit P, Pacharn P, Visitsunthorn N, Vichyanond P, Jirapongsananuruk O. The natural history of chronic urticaria in childhood: a prospective study. J Am Acad Dermatol. 2014 Oct;71(4):663-8. doi: 10.1016/j.jaad.201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.
Description in details:
Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported.
6 years Yes
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