The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
This study has been completed.
Sponsor:
Chulalongkorn University
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00853476
First received: February 27, 2009
Last updated: February 16, 2011
Last verified: February 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 27, 2009 | ||||
| Last Updated Date | February 16, 2011 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00853476 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test | ||||
| Official Title ICMJE | The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test | ||||
| Brief Summary | This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult Healthy Volunteers |
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| Condition ICMJE | Intradermal Test | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00853476 | ||||
| Other Study ID Numbers ICMJE | Chula-ARC 001/09 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jettanong Klaewsongkram, MD, Chulalongkorn University | ||||
| Study Sponsor ICMJE | Chulalongkorn University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chulalongkorn University | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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