Chronic UrticariaNHCUNCT01284426

Natural History of Chronic Urticaria

An observational study of Chronic Urticaria, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 4 to 15 years
Conditions the study is for: Chronic Urticaria
How many people: 94 participants
Where: 1 siteThailand
Study dates: Mar 2003to Mar 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 15 years
All sexes
No healthy volunteers
Child

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700

Other trials in Thailand

About this study

Official title: The Natural History of Chronic Urticaria in Childhood: A Prospective Study

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.

Read the 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.

Conditions: Chronic Urticaria
Keywords: Chronic urticaria, Natural course, Remission
Medical subject headings: Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01284426
Study group	Role	What they receive
Chronic urticaria		Chronic urticaria, Natural history

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Mar 2009

First posted27 Jan 2011 (estimated)
Study startMar 2003
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic UrticariaStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01284426
Sponsor's protocol ID: 374/2551(EC3)
Acronym: NHCU
Status last verified: Dec 2015
First submitted: 20 Jan 2011
Last updated: 1 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25023899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria

All Chronic Urticaria trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Natural History of Chronic Urticaria in Childhood: A Prospective Study
ClinicalTrials.gov ID: NCT01284426
Acronym / sponsor ID: NHCU / 374/2551(EC3)
Conditions: Chronic Urticaria
Keywords: Chronic urticaria, Natural course, Remission
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: Mar 2003
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 27 Jan 2011 (estimated)
Results: Posted 1 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic urticaria	–	–Chronic urticaria, Natural history

Who may qualify

Ages: 4 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, Children 4-15 years of age with chronic urticaria.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Results posted to the registry on 1 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Urticaria	94	92

Primary outcome: Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.

Time frame: 6 years. Number. Unit: percentage of participants

Measure	Chronic Urticaria n = 92
Remission rate at 1 year after the onset	18.5
Remission rate at 3 year after the onset	54
Remission rate at 5 year after the onset	67.7

Population analysed: Children 4-15 years old with chronic urticaria

Adverse events

Time frame: 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Urticaria	0 of 92 (0%)	62 of 92 (67.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25023899Chansakulporn 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.
The natural history of chronic urticaria in childhood: a prospective study.Link provided by the sponsor.

Related trials for Chronic Urticaria

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Orathai Piboonpocanun, Prof. principal investigator

Siriraj Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Urticaria, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed. (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.