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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01935206
Other study ID # H-2-2012-174
Secondary ID
Status Completed
Phase Phase 1
First received August 19, 2013
Last updated February 24, 2014
Start date June 2013
Est. completion date November 2013

Study information

Verified date February 2014
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: regional Research Ethical CommitteeDenmark: Data Protection AgencyDenmark: Danish Medicines AgencyDenmark: Good Clinical Practice unit - University Hospitals Copenhagen
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone (2 mg/kg)

Placebo


Locations

Country Name City State
Denmark Dept Anaesthesiology HOC, 4231, Rigshospitalet Copenhagen
Denmark Multidisciplinary Pain Center Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion Mechanical Pain Thresholds will be assessed with pinprick stimulators at baseline and after infusion of naloxone/placebo at the primary hyperalgesia site (following a first degree burn) and in the contralateral leg. 0h, 168h, 168h30min No
Primary 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. 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn No
Secondary 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. 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn No
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