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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00853476
Other study ID # Chula-ARC 001/09
Secondary ID
Status Completed
Phase N/A
First received February 27, 2009
Last updated February 16, 2011
Start date March 2009
Est. completion date October 2009

Study information

Verified date February 2011
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test 30 minutes No
Secondary Side effects 24 hours Yes