Natural History of Chronic Urticaria (NHCU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01284426
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Chronic Urticaria

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Chronic Urticaria Chronic urticaria, Natural history

Participant Flow:   Overall Study
    Chronic Urticaria

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Remission period, chronic urticaria

Reporting Groups
Chronic Urticaria Chronic urticaria, Natural history

Baseline Measures
   Chronic Urticaria 
Overall Participants Analyzed 
[Units: Participants]
Age [1] 
[Units: Years]
Median (Full Range)
 (4.0 to 15.5) 
[1] Children 4-15 years of age
[Units: Participants]
Female   49 
Male   43 
Region of Enrollment 
[Units: Participants]
Thailand   92 

  Outcome Measures

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Professor Orathai Jirapongsananuruk, Director of Clinical Trials
Organization: Division of Allergy and Immunology, Department of Pediatrics, Siriraj Hospital, Mahidol University
phone: 024197000

Publications of Results:

Responsible Party: Orathai Piboonpocanun, Mahidol University Identifier: NCT01284426     History of Changes
Other Study ID Numbers: 374/2551(EC3)
First Submitted: January 20, 2011
First Posted: January 27, 2011
Results First Submitted: August 21, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016