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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853476
First Posted: March 2, 2009
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chulalongkorn University
  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 ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 24 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00853476     History of Changes
Other Study ID Numbers: Chula-ARC 001/09
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: February 18, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents