Cognitive Ability, GeneralPhase 3NCT01375348
Relationship Between Cognitive Function and Pain
A Phase 3 study of Cognitive Ability, General, run by University of Aarhus at 1 site in Denmark.
Trial summary
Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Feb 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men aged 18-65 years
- Normal vision and hearing
- No disease associated with cognitive dysfunction
Who cannot join
- Allergic to remifentanil or patches
- Any use of pain killers or alcohol 48hours before study start
- Current participation in other clinical studies or participation within the last 14days before study start
- Prescribed medication
- Risk of developing
- Previously alcohol- or drug addict
- MMSE score < 26
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mech-Sense, Department of Gastroenterology, Aalborg Hospital
Aalborg, 9000
About this study
Official title: Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil
Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. The interaction between pain, treatment and cognitive function is very complex and is far from understood.
The hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.
- Conditions
- Cognitive Ability, General
- Being tested
- Ultiva (remifentanil) or placebo
- Keywords
- Cognitive function, Experimental pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultiva (remifentanil) or placeboDrug
Also called Ultiva (remifentanil)
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Investigate the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:
* tonic muscle pain induced by the tourniquet pain model
* cognitive tests
* recording of brain activity by use of 64 channel cap Receives: Drug: Ultiva (remifentanil) or placebo |
| Placebo infusion | Placebo comparator | To blind the study and use as comparator in the investigation of the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:
* tonic muscle induced pain by the tourniquet pain model
* cognitive tests
* brain activity by use of a 64 channel cap Receives: Drug: Ultiva (remifentanil) or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Investigate the relationship between cognitive function and pain and treatment with remifentanil
Measured: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Mech-Sense
- Responsible party
- Sponsor
- Investigators
- Asbjørn M Drewes, Professor, Principal investigator, Mech-Sense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375348
- Sponsor's protocol ID
- Kogprem
- Status last verified
- Feb 2012
- First submitted
- 15 Jun 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjogren P, Drewes AM. Altered frequency distribution in the electroencephalogram is correlated to the analgesic effect of remifentanil. Basic Clin Pharmacol Toxicol. 2015 May;116(5):414-22. doi: 10.1111/bcpt.12330. Epub 2014 Oct 21.
PubMed 25250670
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil
- ClinicalTrials.gov ID
- NCT01375348
- Acronym / sponsor ID
- Kogprem
- Conditions
- Cognitive Ability, General
- Keywords
- Cognitive function, Experimental pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Mech-Sense
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Jun 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.
Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. The interaction between pain, treatment and cognitive function is very complex and is far from understood.
The hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: Ultiva (remifentanil) or placeboInvestigate the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models: * tonic muscle pain induced by the tourniquet pain model * cognitive tests * recording of brain activity by use of 64 channel cap |
| Placebo infusion | Placebo comparator | Drug: Ultiva (remifentanil) or placeboTo blind the study and use as comparator in the investigation of the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models: * tonic muscle induced pain by the tourniquet pain model * cognitive tests * brain activity by use of a 64 channel cap |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men aged 18-65 years
- Normal vision and hearing
- No disease associated with cognitive dysfunction
Key exclusion criteria (7 listed)
- Allergic to remifentanil or patches
- Any use of pain killers or alcohol 48hours before study start
- Current participation in other clinical studies or participation within the last 14days before study start
- Prescribed medication
- Risk of developing
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 |
|---|---|---|
| Ultiva (remifentanil) or placeboAlso: Ultiva (remifentanil)0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min | Drug | Placebo infusion, Remifentanil |
Primary outcome
Cognitive function
Time frame: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
Investigate the relationship between cognitive function and pain and treatment with remifentanil
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 Feb 2012.
- Derived from this study: PubMed 25250670Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjogren P, Drewes AM. Altered frequency distribution in the electroencephalogram is correlated to the analgesic effect of remifentanil. Basic Clin Pharmacol Toxicol. 2015 May;116(5):414-22. doi: 10.1111/bcpt.12330. Epub 2014 Oct 21.
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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 M Drewes, Professor principal investigator
Mech-Sense
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 of Cognitive Ability, General, 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 3 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 14 Feb 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?
Cognitive function (time frame: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month). 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 NCT01375348, which also lists 1 linked publication.
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 Feb 2012.