NCT01284426

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

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

March 1, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
5 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

December 1, 2015

Enrollment Period

6 years

First QC Date

January 20, 2011

Results QC Date

August 21, 2015

Last Update Submit

December 30, 2015

Conditions

Keywords

Chronic urticariaNatural courseRemission

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Chronic urticaria

Chronic urticaria, Natural history

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, Children 4-15 years of age with chronic urticaria.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related 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.2014.05.069. Epub 2014 Jul 11.

Related Links

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study did not perform basophil histamine releasing assay to identify the existence of functional autoantibodies, since there was no available laboratory to do this test.

Results Point of Contact

Title
Professor Orathai Jirapongsananuruk, Director of Clinical Trials
Organization
Division of Allergy and Immunology, Department of Pediatrics, Siriraj Hospital, Mahidol University

Study Officials

  • Orathai Piboonpocanun, Prof.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 27, 2011

Study Start

March 1, 2003

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 1, 2016

Results First Posted

February 1, 2016

Record last verified: 2015-12

Locations