PainPhase 3NCT00647127
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
A Phase 3 study testing Buprenorphine and Fentanyl in people with Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Pain
- What is being tested?
- Buprenorphine and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Jan 2010
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- men > 18 years
Who cannot join
- women
- known allergy against the investigated drugs
- ongoing participation in other experiments or participation in other experiments 14 days before screening
- previously pain or psychiatric conditions
- simultaneously use of pain killers
- alcohol
Show all 11Show fewer
- previously drug-addict or member of family with drug-addicts
- chronic constipation
- ileus
- inflammatory bowel syndrome
- abdominal surgery within the last three months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mech Sense, Department of Gastroenterology
Aalborg, Region Nordjyllan, 9000
About this study
To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.
- Conditions
- Pain
- Being tested
- Buprenorphine, Fentanyl, Placebo
- Keywords
- Buprenorphine, Fentanyl, Analgesic effect, Anti-hyperalgesic effect, Experimental pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called Norspan
Buprenorphine: 20microg/h
FentanylDrug
Also called Durogesic
Fentanyl: 25microg/h
PlaceboDrug
Also called Norspan
Placebo: '5microg/h' (not active drug, it is just called '5microg/h')
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Active comparator | Not described Receives: Drug: Buprenorphine |
| Fentanyl | Active comparator | Not described Receives: Drug: Fentanyl |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale.
Measured: Continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionJan 2010
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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asbjoern M Drewes, MD, Prof., Principal investigator, Mech Sense, Department of Gastroenterology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647127
- Sponsor's protocol ID
- 2007-004524-21
- Status last verified
- Sep 2012
- First submitted
- 26 Mar 2008
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
- ClinicalTrials.gov ID
- NCT00647127
- Acronym / sponsor ID
- 2007-004524-21
- Conditions
- Pain
- Keywords
- Buprenorphine, Fentanyl, Analgesic effect, Anti-hyperalgesic effect, Experimental pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Mar 2008 (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.
To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Active comparator | Drug: Buprenorphine |
| Fentanyl | Active comparator | Drug: Fentanyl |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent
- men > 18 years
Key exclusion criteria (11 listed)
- women
- known allergy against the investigated drugs
- ongoing participation in other experiments or participation in other experiments 14 days before screening
- previously pain or psychiatric conditions
- simultaneously use of pain killers
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 |
|---|---|---|
| BuprenorphineAlso: NorspanBuprenorphine: 20microg/h | Drug | Buprenorphine |
| FentanylAlso: DurogesicFentanyl: 25microg/h | Drug | Fentanyl |
| PlaceboAlso: NorspanPlacebo: '5microg/h' (not active drug, it is just called '5microg/h') | Drug | Placebo |
Primary outcome
Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale.
Time frame: Continuously
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 14 Sep 2012.
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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.
Asbjoern M Drewes, MD, Prof. principal investigator
Mech Sense, Department of Gastroenterology, Aalborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine and Fentanyl in people with 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 2 inclusion and 11 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 14 Sep 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale. (time frame: Continuously). It is what the study was designed to measure, not a finding.
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 14 Sep 2012.