HyperalgesiaPhase 4RemiCaps2NCT00789386
The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
A Phase 4 study testing Remifentanil and Midazolam in people with Hyperalgesia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- Remifentanil and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2008to Dec 2009
- Phase
- Phase 4
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination
- Drug free for 1 week prior to the study day
Who cannot join
- Regular use of medication especially analgesics
- Abuse of alcoholic beverages, drug abuse
- History of asthma
- Participation in a clinical trial in the 2 weeks preceding the study
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- Resting systolic blood pressure > 135 mmHg or diastolic blood pressure > 85 mmHg
- Acute skin diseases like sunburn on the relevant areas or skin lesions
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Anaesthesia, Medical University of Vienna
Vienna, 1090
Astrid Chiari, MD
Burkhard Gustorff, MD
About this study
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.
Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.
Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.
- Conditions
- Hyperalgesia
- Being tested
- Remifentanil, Midazolam
- Keywords
- Capsaicin, Remifentanil, Hyperalgesia
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Remifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes.
MidazolamDrug
Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | Not described Receives: Drug: Remifentanil |
| Midazolam | Placebo comparator | Active Placebo Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of pin prick hyperalgesia
Measured: 0-6 hours
Secondary outcomes (5)
Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)
Measured: 0-6 hours
Pain immediately after injection
Measured: 0-15 minutes
Heat pain threshold within the area of mechanical hyperalgesia
Measured: 0-6 hours
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Measured: 0-6 hours
Adverse effects
Measured: 10 and 30 min after infusion of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Burkhard Gustorff, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789386
- Sponsor's protocol ID
- VHPRG-RemiCaps2
- Other IDs
- LS07-040
- Acronym
- RemiCaps2
- Status last verified
- May 2009
- First submitted
- 10 Nov 2008
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
- ClinicalTrials.gov ID
- NCT00789386
- Acronym / sponsor ID
- RemiCaps2 / VHPRG-RemiCaps2
- Conditions
- Hyperalgesia
- Keywords
- Capsaicin, Remifentanil, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 11 Nov 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.
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.
Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.
Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: Remifentanil |
| Midazolam | Placebo comparator | Drug: MidazolamActive Placebo |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination
- Drug free for 1 week prior to the study day
Key exclusion criteria (8 listed)
- Regular use of medication especially analgesics
- Abuse of alcoholic beverages, drug abuse
- History of asthma
- Participation in a clinical trial in the 2 weeks preceding the study
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
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 |
|---|---|---|
| RemifentanilRemifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes. | Drug | Remifentanil |
| MidazolamMidazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil. | Drug | Midazolam |
Primary outcome
Area of pin prick hyperalgesia
Time frame: 0-6 hours
5 secondary outcomes
Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)
Time frame: 0-6 hours
Pain immediately after injection
Time frame: 0-15 minutes
Heat pain threshold within the area of mechanical hyperalgesia
Time frame: 0-6 hours
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Time frame: 0-6 hours
Adverse effects
Time frame: 10 and 30 min after infusion of study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
Related trials for Hyperalgesia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
RecruitingPhase 3
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Fibromyalgia
Recruiting
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Pain, Chronic, Facet Joint Pain
Not yet recruitingObservational study
Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery
Postoperative Pain, Chronic Postsurgical Pain
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.
Burkhard Gustorff, MD study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Midazolam in people with Hyperalgesia, run by Medical University of Vienna at 1 site in Austria.
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 8 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: status not confirmed, as of the sponsor's last update on 21 May 2009. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael H Andreae, MD (+436769677181, michael@andreae.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of pin prick hyperalgesia (time frame: 0-6 hours). 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 21 May 2009.