Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

February 8, 2022 updated by: Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs

Description

Inclusion Criteria:

  • Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NSAID sensitivity
Patients diagnosed with an immediate reaction to aspirin/NSAIDs/or paracetamol
Drug: aspirin, NSAIDs, paracetamol
Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of skin test/provocation test
Time Frame: 4 years
Positive, negative, or equivocal
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Phenotypes of allergic reactions
Time Frame: 4 years
4 years
Urine leukotriene E4
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chula-ARC 002/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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