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Natural History of Chronic Urticaria (NHCU)

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ClinicalTrials.gov Identifier: NCT01284426
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University

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.

Condition or disease
Chronic Urticaria

Detailed 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.

Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Natural History of Chronic Urticaria in Childhood: A Prospective Study
Study Start Date : March 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Group/Cohort
Chronic urticaria
Chronic urticaria, Natural history



Primary Outcome Measures :
  1. Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. [ Time Frame: 6 years ]

    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.




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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, Children 4-15 years of age with chronic urticaria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284426


Locations
Thailand
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Orathai Piboonpocanun, Prof. Siriraj Hospital

Additional Information:
Publications of Results:
Responsible Party: Orathai Piboonpocanun, Prof., Mahidol University
ClinicalTrials.gov Identifier: NCT01284426     History of Changes
Other Study ID Numbers: 374/2551(EC3)
First Posted: January 27, 2011    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016
Last Verified: December 2015

Keywords provided by Orathai Piboonpocanun, Mahidol University:
Chronic urticaria
Natural course
Remission

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases