Natural History of Chronic Urticaria (NHCU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University
ClinicalTrials.gov Identifier:
NCT01284426
First received: January 20, 2011
Last updated: December 30, 2015
Last verified: December 2015
  Purpose
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
Chronic Urticaria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Natural History of Chronic Urticaria in Childhood: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 94
Study Start Date: March 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic urticaria
Chronic urticaria, Natural history

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.
  Eligibility

Ages Eligible for Study:   4 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Orathai Piboonpocanun, Prof., Mahidol University
ClinicalTrials.gov Identifier: NCT01284426     History of Changes
Other Study ID Numbers: 374/2551(EC3) 
Study First Received: January 20, 2011
Results First Received: August 21, 2015
Last Updated: December 30, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Chronic urticaria
Natural course
Remission

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

ClinicalTrials.gov processed this record on August 22, 2016