HyperalgesiaPhase 1NCT01935206
Effect of High Dose Naloxone on Secondary Hyperalgesia
A Phase 1 study testing Naloxone (2 mg/kg) in people with Hyperalgesia and Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia, Pain, Naloxone
- What is being tested?
- Naloxone (2 mg/kg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2013to Nov 2013
- Phase
- Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy man
- written informed consent
- ASA 1-2
- BMI 18 < BMI < 30
- normal ultrasound examination of the heart
- normal ECG
- urin sample without traces of opioids
Who cannot join
- volunteers, who do not understand the Danish language
- participation in another experimental trial in the previous 60 days
- nerve damage or skin lesions in the assessment areas
- neurological or psychiatric condition
- use of psycho-active drugs
- abuse of alcohol or drugs
Show all 13Show fewer
- chronic pain
- regular use of pain-killers (> 1 a week)
- allergy against morphine or other opioids (including naloxone)
- use of prescription drugs 1 week prior to the trial
- use of over-the-counter medication 48 hours prior to the trial
- urin sample with traces of opioids
- volunteer is not suitable for the trial according to the investigator's consideration
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept Anaesthesiology HOC, 4231, Rigshospitalet
Copenhagen, Copenhagen, 2100
Multidisciplinary Pain Center
Copenhagen, Copenhagen, 2100
About this study
Official title: Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.
- Conditions
- Hyperalgesia, Pain, Naloxone, Opioid Antagonist
- Being tested
- Naloxone (2 mg/kg), Placebo
- Keywords
- secondary hyperalgesia, allodynia, mechanical pain threshold, naloxone, endogenous opioids, pain
- Medical subject headings
- Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone (2 mg/kg)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. Receives: Drug: Placebo |
| Naloxone (2 mg/kg) | Experimental | The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. Receives: Drug: Naloxone (2 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
Measured: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Secondary outcomes (1)
Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Areas of allodynia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
Measured: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
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 Copenhagen University Hospital, RigshospitaletThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Pereira, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Joergen B Dahl, M.D., DMSc, Study director, Dept Anaesthesiology, HOC, 4231, RigshospitaletMads U. Werner, M.D., Ph.D., DMSc, Principal investigator, Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935206
- Sponsor's protocol ID
- H-2-2012-174
- Status last verified
- Feb 2014
- First submitted
- 19 Aug 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn
- ClinicalTrials.gov ID
- NCT01935206
- Acronym / sponsor ID
- H-2-2012-174
- Conditions
- Hyperalgesia, Pain, Naloxone, Opioid Antagonist
- Keywords
- secondary hyperalgesia, allodynia, mechanical pain threshold, naloxone, endogenous opioids, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Sep 2013 (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.
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. |
| Naloxone (2 mg/kg) | Experimental | Drug: Naloxone (2 mg/kg)The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy man
- written informed consent
- ASA 1-2
- BMI 18 < BMI < 30
- normal ultrasound examination of the heart
Key exclusion criteria (13 listed)
- volunteers, who do not understand the Danish language
- participation in another experimental trial in the previous 60 days
- nerve damage or skin lesions in the assessment areas
- neurological or psychiatric condition
- use of psycho-active drugs
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 |
|---|---|---|
| Naloxone (2 mg/kg) | Drug | Naloxone (2 mg/kg) |
| Placebo | Drug | Placebo |
Primary outcome
Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Time frame: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
1 secondary outcome
Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Time frame: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
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 25 Feb 2014.
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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.
Joergen B Dahl, M.D., DMSc study director
Dept Anaesthesiology, HOC, 4231, Rigshospitalet
Mads U. Werner, M.D., Ph.D., DMSc principal investigator
Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxone (2 mg/kg) in people with Hyperalgesia and Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 7 inclusion and 13 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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?
Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo (time frame: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn). 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 25 Feb 2014.