PainPASORIINCT01296334
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine
A study testing morphine LO, Morphine Hi and Buprenorphine LO in people with Pain, run by mads u werner at 1 site in Denmark.
Trial summary
Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- morphine LO, Morphine Hi and Buprenorphine LO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Oct 2011
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals
- adequate psychomotor performance to perform pain tests
- pain-sensitive or pain-nonsensitive according to prespecified criteria
Who cannot join
- known allergy to morphine or buprenorphine
- prior adverse experiences with opioids
- history of abuse
- females not taking P-pills
- skin lesions on the test-sites
- suffering from chronic pain
Show all 9Show fewer
- medication with analgesics
- BMI > 28
- smoker
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital
Copenhagen NV, 2400
About this study
Official title: Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.
Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.
The objectives are:
- to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
- to investigate if these effects are related to the volunteers individual pain sensitivity
Read the detailed description
Please refer to:
Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 [doi];jpr-6-023 [pii].
- Conditions
- Pain
- Being tested
- morphine LO, Morphine Hi, Buprenorphine LO, Buprenorphine Hi, saline
- Keywords
- opioids, analgesia, secondary hyperalgesia, quantitative sensory testing, inflammatory injury
- Medical subject headings
- Pain, Agnosia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine LODrug
Also called Morfin SAD
intravenous infusion, 10 mg, once, 4 hours
Morphine HiDrug
Also called Morfin SAD
intravenous infusion, 20 mg, once, 4 hours
Buprenorphine LODrug
Also called Temgesic
intravenous infusion, 0.3 mg, once, 4 hours
Buprenorphine HiDrug
Also called Temgesic
intravenous infusion, 0.6 mg, once, 4 hours
salineOther
Also called 0.9% NaCl
intravenous infusion, 0.9% saline, once, 4 hours
| Study group | Role | What they receive |
|---|---|---|
| morphine low dose | Experimental | morphine infusion 10 mg over a 210 min period Receives: Drug: morphine LO |
| morphine high dose | Experimental | morphine infusion 20 mg over a 210 min period Receives: Drug: Morphine Hi |
| buprenorphine low dose | Experimental | buprenorphine infusion 0.3 mg over a 210 min period Receives: Drug: Buprenorphine LO |
| buprenorphine high dose | Experimental | buprenorphine infusion 0.6 mg over a 210 min period Receives: Drug: Buprenorphine Hi |
| placebo | Placebo comparator | placebo (normal saline) infusion 0.6 mg over a 210 min period Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic and antihyperalgesic effects
Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
Measured: 0 to 180 min after a first degree burn injury
Secondary outcomes (1)
Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals
The ratios between areas under curve (0-180 min after first degree burn injury) for analgesic effect assessed by change in primary hyperalgesia (pain rating VAS])and antihyperalgesic effect assessed by reduction in area of hyperalgesia (sq. cm).
Measured: 0-180 min after first degree burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- mads u werner
- Sponsor type
- University, hospital or other
- Collaborators
- Norpharma A/S
- Responsible party
- Sponsor-investigator, mads u werner, University of Copenhagen
- Investigators
- Mads U Werner, MD, DMSc, Study director, Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen OLona L Christrup, MSc, PhD, Study chair, Pharmaceutical Faculty, Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296334
- Sponsor's protocol ID
- H-2-2010-115
- Other IDs
- 2010-022903-23
- Acronym
- PASORII
- Status last verified
- Nov 2016
- First submitted
- 14 Feb 2011
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.
PubMed 16154698Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.
PubMed 23359655
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.
- ClinicalTrials.gov ID
- NCT01296334
- Acronym / sponsor ID
- PASORII / H-2-2010-115
- Conditions
- Pain
- Keywords
- opioids, analgesia, secondary hyperalgesia, quantitative sensory testing, inflammatory injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- mads u wernerUniversity, hospital or other
- Collaborators
- Norpharma A/S
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Feb 2011 (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.
Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.
The objectives are:
- to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
- to investigate if these effects are related to the volunteers individual pain sensitivity
Detailed description
Please refer to:
Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 [doi];jpr-6-023 [pii].
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| morphine low dose | Experimental | Drug: morphine LOmorphine infusion 10 mg over a 210 min period |
| morphine high dose | Experimental | Drug: Morphine Himorphine infusion 20 mg over a 210 min period |
| buprenorphine low dose | Experimental | Drug: Buprenorphine LObuprenorphine infusion 0.3 mg over a 210 min period |
| buprenorphine high dose | Experimental | Drug: Buprenorphine Hibuprenorphine infusion 0.6 mg over a 210 min period |
| placebo | Placebo comparator | Other: salineplacebo (normal saline) infusion 0.6 mg over a 210 min period |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy individuals
- adequate psychomotor performance to perform pain tests
- pain-sensitive or pain-nonsensitive according to prespecified criteria
Key exclusion criteria (9 listed)
- known allergy to morphine or buprenorphine
- prior adverse experiences with opioids
- history of abuse
- females not taking P-pills
- skin lesions on the test-sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphine LOAlso: Morfin SADintravenous infusion, 10 mg, once, 4 hours | Drug | morphine low dose |
| Morphine HiAlso: Morfin SADintravenous infusion, 20 mg, once, 4 hours | Drug | morphine high dose |
| Buprenorphine LOAlso: Temgesicintravenous infusion, 0.3 mg, once, 4 hours | Drug | buprenorphine low dose |
| Buprenorphine HiAlso: Temgesicintravenous infusion, 0.6 mg, once, 4 hours | Drug | buprenorphine high dose |
| salineAlso: 0.9% NaClintravenous infusion, 0.9% saline, once, 4 hours | Other | placebo |
Primary outcome
Analgesic and antihyperalgesic effects
Time frame: 0 to 180 min after a first degree burn injury
Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
1 secondary outcome
Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals
Time frame: 0-180 min after first degree burn injury
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 28 Nov 2016.
- Background: PubMed 16154698Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.
- Results publication: PubMed 23359655Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.
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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.
Mads U Werner, MD, DMSc study director
Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O
Lona L Christrup, MSc, PhD study chair
Pharmaceutical Faculty, Copenhagen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morphine LO, Morphine Hi and Buprenorphine LO in people with Pain, run by mads u werner 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 3 inclusion and 9 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 28 Nov 2016. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Analgesic and antihyperalgesic effects (time frame: 0 to 180 min after a first degree burn injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296334, which also lists 2 linked publications.
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 28 Nov 2016.