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Caffeine-mediated modulation of human experimental pain models

Caffeine-mediated modulation of human experimental pain models

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000408-16-SE
Enrollment
Unknown
Registered
2005-02-11
Start date
2005-04-05
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy human volunteer subjects

Interventions

Product Name: Caffeine sodium benzoate, 250 mg/ml Pharmaceutical Form: Intravenous infusion Other descriptive name: Caffeine Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal C

Sponsors

Karolinska University Hospital, Huddinge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Both male and female subjects between the age of 18 and 55 will be included. Subjects should be healthy without on-going long-term medication. All participation will be on voluntary basis and informed written and verbal consent will be acquired from all subjects. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ·History of any disease that might influence results or cause increased danger or discomfort to the subject. Especially, previous history of cardiac arrhythmias, long-term pain disorder or sleep or mood disorders. ·Consumption of caffeine or xanthine containing beverages and foodstuffs, e.g. tea, chocolate and certain soft drinks in excess of 300 mg/day, corresponding to more than 3-4 cups of coffee/day. ·Any acute signs of illness or infection one week before experiment. ·Overweight, BMI >30. ·Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: A. To study the analgesic properties of caffeine, and primarily determine the site of action, peripheral or central, by use of a tourniquet model for ischemic pain. B. To study the analgesic and anti-inflammatory properties of caffeine after a skin burn injury. Any changes in secondary hyperalgesia are of special interest. ;Secondary Objective: ;Primary end point(s):

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026