Acute PainPhase 1/2RemiclonNCT00730054
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
A Phase 1/2 study testing Remifentanil+clonidine in people with Acute Pain and Respiration, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Respiration, Sedation
- What is being tested?
- Remifentanil+clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2005to May 2005
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
Oslo, 0027
About this study
The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.
Read the detailed description
To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.
- Conditions
- Acute Pain, Respiration, Sedation
- Being tested
- Remifentanil+clonidine
- Keywords
- Remifentanil, clonidine, acute pain, respiration, sedation, cognitive function
- Medical subject headings
- Acute Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil+clonidineDrug
Also called Ultiva, Catapressan
iv Remifentanil+ iv clonidine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clonidine Receives: Drug: Remifentanil+clonidine |
| 2 | Active comparator | Remifentanil Receives: Drug: Remifentanil+clonidine |
| 4 | Experimental | Remifentanil+clonidine Receives: Drug: Remifentanil+clonidine |
| 3 | Placebo comparator | Placebo Receives: Drug: Remifentanil+clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of pain(VAS reduction)
Measured: Experimental
Secondary outcomes (4)
Reduction in Minute ventilation
Measured: Experimental
Reduction in CO2 stimulated Minute Ventilation
Measured: experimental
Reduction in BIS score
Measured: Experimental
Performance on Stroop test
Measured: Experimental
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startFeb 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jon B Bergmann, Ass. Prof., Principal investigator, Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730054
- Sponsor's protocol ID
- S-03025
- Acronym
- Remiclon
- Status last verified
- Aug 2008
- First submitted
- 6 Aug 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00730054
- Acronym / sponsor ID
- Remiclon / S-03025
- Conditions
- Acute Pain, Respiration, Sedation
- Keywords
- Remifentanil, clonidine, acute pain, respiration, sedation, cognitive function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 Aug 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.
The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.
Detailed description
To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Remifentanil+clonidineClonidine |
| 2 | Active comparator | Drug: Remifentanil+clonidineRemifentanil |
| 4 | Experimental | Drug: Remifentanil+clonidineRemifentanil+clonidine |
| 3 | Placebo comparator | Drug: Remifentanil+clonidinePlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Remifentanil+clonidineAlso: Ultiva, Catapressaniv Remifentanil+ iv clonidine | Drug | 1, 2, 3, 4 |
Primary outcome
Relief of pain(VAS reduction)
Time frame: Experimental
4 secondary outcomes
Reduction in Minute ventilation
Time frame: Experimental
Reduction in CO2 stimulated Minute Ventilation
Time frame: experimental
Reduction in BIS score
Time frame: Experimental
Performance on Stroop test
Time frame: Experimental
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 6 Jul 2011.
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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.
Jon B Bergmann, Ass. Prof. principal investigator
Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remifentanil+clonidine in people with Acute Pain and Respiration, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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 6 Jul 2011. 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 Norway. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Relief of pain(VAS reduction) (time frame: Experimental). 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 6 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.