- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00853476
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
February 16, 2011 updated by: Chulalongkorn University
This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
25
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
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-
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Bangkok, Thailand, 10330
- Faculty of Medicine, Chulalongkorn University
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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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Healthy Volunteers
Description
Inclusion Criteria:
- age 18-60 years old
Exclusion Criteria:
- immunodeficiency state
- cancer
- severe skin diseases
- severe medical illnesses
- malnutrition
- uncontrolled asthma
- 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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side effects
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University
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
March 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
February 27, 2009
First Submitted That Met QC Criteria
February 27, 2009
First Posted (Estimate)
March 2, 2009
Study Record Updates
Last Update Posted (Estimate)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 16, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- Chula-ARC 001/09
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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