Intradermal TestNCT00853476
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
An observational study of Intradermal Test, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intradermal Test
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2009to Oct 2009
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult Healthy Volunteers
Who may be able to join
- age 18-60 years old
Who cannot join
- immunodeficiency state
- cancer
- severe skin diseases
- severe medical illnesses
- malnutrition
- uncontrolled asthma
Show all 13Show fewer
- pregnancy
- received oral or systemic corticosteroid within 1 month before this study
- receiving immunosuppressive agents
- taken antihistamine within 3 days before this study
- taking beta-blocker
- previous history of immunotherapy
- have hypersensitivity reaction to morphine/opiates
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.
Read the detailed description
Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.
- Conditions
- Intradermal Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test
Measured: 30 minutes
Secondary outcomes (1)
Side effects
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradermal TestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853476
- Sponsor's protocol ID
- Chula-ARC 001/09
- Status last verified
- Feb 2011
- First submitted
- 27 Feb 2009
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
- ClinicalTrials.gov ID
- NCT00853476
- Acronym / sponsor ID
- Chula-ARC 001/09
- Conditions
- Intradermal Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 2 Mar 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.
This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.
Detailed description
Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult Healthy Volunteers
Key inclusion criteria (1 listed)
- age 18-60 years old
Key exclusion criteria (13 listed)
- immunodeficiency state
- cancer
- severe skin diseases
- severe medical illnesses
- malnutrition
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
Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test
Time frame: 30 minutes
1 secondary outcome
Side effects
Time frame: 24 hours
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 Feb 2011.
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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.
Jettanong Klaewsongkram, 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?
An observational study of Intradermal Test, 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 1 inclusion and 13 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 Feb 2011. 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?
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?
Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test (time frame: 30 minutes). 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 Feb 2011.