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

This study has been completed.

First Received on February 27, 2009. Last Updated on February 16, 2011 History of Changes

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:	Observational Model: Cohort Time Perspective: 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 ]

Enrollment:	25
Study Start Date:	March 2009
Study Completion Date:	October 2009
Primary Completion Date:	October 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

Locations

Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:

Jettanong Klaewsongkram, MD

Chulalongkorn University

More Information

Additional Information:

http://www.ncbi.nlm.nih.gov/pubmed/21314010 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00853476 History of Changes
Other Study ID Numbers:	Chula-ARC 001/09
Study First Received:	February 27, 2009
Last Updated:	February 16, 2011
Health Authority:	Thailand: Ethical Committee

Additional relevant MeSH terms:

Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012