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Investigation of the antihyperalgesic effect of a combination of tramadol and paracetamol on primary and secondary hyperalgesia in an UV-B induced inflammatory skin pain model in healthy volunteers. - TramaPara in sunburn

Investigation of the antihyperalgesic effect of a combination of tramadol and paracetamol on primary and secondary hyperalgesia in an UV-B induced inflammatory skin pain model in healthy volunteers. - TramaPara in sunburn

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001639-30-AT
Enrollment
30
Registered
2006-08-30
Start date
2006-10-02
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

This is a volunteer study in healthy volunteers.

Interventions

Pharmaceutical Form: Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Pharmaceutical Form: Pharmaceutical form of the placebo: Intrav

Sponsors

Department of Anaesthesia&Intensive Care B, Vienna Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: healthy volunteers (both male and female) ;age 19-40 yrs., body mass index between 15th and 85th percentile, drug free, right-handed. 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) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not healthy, oder than 40 years

Design outcomes

Primary

MeasureTime frame
Secondary Objective: ;Main Objective: In this study the following hypotheses will be tested: ? Paracetamol has a dose dependant antihyperalgesic effect on primary and secondary hyperalgesia. ? Single dose tramadol has an antihyperalgesic effect on primary and secondary hyperalgesia. ? The combination of single dose tramadol with multidose paracetamol is superior to the effect of a single drug alone. ? This effect is dose dependent and more pronounced inversely to the dose of paracetamol.? ;Primary end point(s): ?heat pain perception threshold (HPPT) in the inflamed area (primary hyperalgesia) .

Countries

Austria

Outcome results

None listed

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