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

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00853476
First received: February 27, 2009
Last updated: February 16, 2011
Last verified: February 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

ClinicalTrials.gov processed this record on August 26, 2014