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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00489684
First received: June 20, 2007
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: 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

Further study details as provided by University of Aarhus:

Biospecimen Retention:   Samples With DNA

Blood samples are collected to study the pharmacokinetic of the drugs


Enrollment: 24
Study Start Date: August 2007
Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers

Criteria

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
  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: NCT00489684

Locations
Denmark
Gastroenterological outpatients clinic
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Asbjørn Mohr Drewes, Professor Aalborg Hospital S. Gastroenterological Outpatients clinic
  More Information

No publications provided

Responsible Party: Professor Asbjørn Mohr Drewes, Gastroenterological Outpatients Clinic, Aalborg Hospital, Aalborg
ClinicalTrials.gov Identifier: NCT00489684     History of Changes
Other Study ID Numbers: 2007-001881-33
Study First Received: June 20, 2007
Last Updated: June 13, 2008
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hyperalgesia
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders

ClinicalTrials.gov processed this record on October 23, 2014