HypersensitivityNCT00819494
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
A study testing Skin tests with radiocontrast media in people with Hypersensitivity, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Skin tests with radiocontrast media
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with history of immediate hypersensitivity reactions to iodinated contrast media
- 15-70 years of age
Who cannot join
- On antihistamine/ cannot discontinue antihistamine before the test
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.
- Conditions
- Hypersensitivity
- Being tested
- Skin tests with radiocontrast media
- Keywords
- Contrast media skin test, Skin test, hypersensitivity, contrast media
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin tests with radiocontrast mediaProcedure or surgery
Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Sham comparator | Not described Receives: Procedure: Skin tests with radiocontrast media |
| Patients with immediate reactions | Active comparator | Not described Receives: Procedure: Skin tests with radiocontrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media
Measured: 5 months
Secondary outcomes (1)
Blood in vitro test from patients with a history of immediate reactions to radiocontrast media
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819494
- Sponsor's protocol ID
- Chula-ARC 003/08
- Status last verified
- Nov 2010
- First submitted
- 8 Jan 2009
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
- ClinicalTrials.gov ID
- NCT00819494
- Acronym / sponsor ID
- Chula-ARC 003/08
- Conditions
- Hypersensitivity
- Keywords
- Contrast media skin test, Skin test, hypersensitivity, contrast media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
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 trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Sham comparator | Procedure: Skin tests with radiocontrast media |
| Patients with immediate reactions | Active comparator | Procedure: Skin tests with radiocontrast media |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with history of immediate hypersensitivity reactions to iodinated contrast media
- 15-70 years of age
Key exclusion criteria (4 listed)
- On antihistamine/ cannot discontinue antihistamine before the test
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin tests with radiocontrast mediaSkin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media | Procedure or surgery | Healthy controls, Patients with immediate reactions |
Primary outcome
Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media
Time frame: 5 months
1 secondary outcome
Blood in vitro test from patients with a history of immediate reactions to radiocontrast media
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
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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.
Kiat Ruxrungtham, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin tests with radiocontrast media in people with Hypersensitivity, run by Chulalongkorn 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 2 inclusion and 4 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 18 Nov 2010. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2010.