PainAEO-2007-01NCT00489684
Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles
An observational study of Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Between 18 and 65 years
- Signed informed concent
- Healthy
- Women must use a safe contraceptive method
- Negative pregnancy test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Medical subject headings
- Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startAug 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Asbjørn Mohr Drewes, Professor, Principal investigator, Aalborg Hospital S. Gastroenterological Outpatients clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489684
- Sponsor's protocol ID
- 2007-001881-33
- Acronym
- AEO-2007-01
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2007
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00489684
- Acronym / sponsor ID
- AEO-2007-01 / 2007-001881-33
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- Between 18 and 65 years
- Signed informed concent
- Healthy
- Women must use a safe contraceptive method
- Negative pregnancy test
Key exclusion criteria (7 listed)
- Pregnancy
- Allergy to study medication
- Participating in another medicine study
- Previous addictive behaviour
- Need for other treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asbjørn Mohr Drewes, Professor principal investigator
Aalborg Hospital S. Gastroenterological Outpatients clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008.