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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01015482
Other study ID # HighDose RemiSun
Secondary ID
Status Recruiting
Phase Phase 4
First received November 17, 2009
Last updated November 17, 2009
Start date November 2009
Est. completion date April 2010

Study information

Verified date November 2009
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical 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 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.

UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date April 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- UV sensitive skin conditions, like Xeroderma pigmentosa

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil
Remifentanil Infusion
Midazolam
Midazolam Infusion

Locations

Country Name City State
Austria Department of Anaesthesia, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure: Area of pin prick hyperalgesia 0-6h No
Secondary Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) 0-6h No
Secondary Heat pain threshold within the area of mechanical hyperalgesia 0-6h No
Secondary Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush 0-6h No
Secondary Adverse effects 30 and 59 min after start of treatment Yes
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