Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles (AEO-2007-01)

June 13, 2008 updated by: University of Aarhus

Investigation of the Effect of Opioids on Experimental Hyperalgesia in Oesophagus and Skin, and in an Ischemic Model of Musclepain. Including an Explorative Study of the Effect of Morphine on the Pain Processing in the Brain

The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Study Overview

Status

Completed

Conditions

Detailed Description

The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids, Oxycodone and Morphine will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Gastroenterological outpatients clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  • Between 18 and 65 years
  • Signed informed concent
  • Healthy
  • Women must use a safe contraceptive method
  • Negative pregnancy test

Exclusion Criteria:

  • Pregnancy
  • Allergy to study medication
  • Participating in another medicine study
  • Previous addictive behaviour
  • Need for other treatments
  • Use of strong analgesics
  • Use of any analgesics 24 hours before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Asbjørn Mohr Drewes, Professor, Aalborg Hospital S. Gastroenterological Outpatients clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-001881-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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