The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

This study is not yet open for participant recruitment.

Verified by Chulalongkorn University, February 2009

First Received: February 27, 2009 No Changes Posted

Sponsor:	Chulalongkorn University
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00853476

Purpose

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

Condition
Intradermal Test

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	25
Study Start Date:	March 2009
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adult Healthy Volunteers

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853476

Contacts

Contact: Jettanong Klaewsongkram, MD	662-2564152	jettanong.K@chula.ac.th
Contact: Arsa Thammahong	662-2564152

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:

Jettanong Klaewsongkram, MD

Chulalongkorn University

More Information

No publications provided

Responsible Party:	Chulalongkorn University ( Jettanong Klaewsongkram, MD )
Study ID Numbers:	Chula-ARC 001/09
Study First Received:	February 27, 2009
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00853476 History of Changes
Health Authority:	Thailand: Ethical Committee

ClinicalTrials.gov processed this record on November 20, 2009