A double-blind placebo-controlled four period crossover study of paracetamol and tramadol in the electrical hyperalgesia model of central sensitisation in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005211-28-DE

Enrollment

Registered

2005-09-15

Start date

2005-07-20

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

The primary aim of the present study is to investigate the effects of intravenous paracetamol and tramadol and their combination on the experimentally-induced central sensitization in an electrical hyperagesia model, using dosing regimens utilised in the clinic in a double-blind, placebo-controlled and ramdomized cross-over design.

Interventions

Trade Name: Perfalgan Product Name: Perfalgan Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Paracetamol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers, male and female, age 18-45 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: Illness

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of intravenous paracetamol and tramadol on the areas of hyperalgesia and allodynia in an electrical hyperalgesia model in healthy volunteers.;Secondary Objective: To investigate the effects of intravenous paracetamol and tramadol on pain and flare in an electrical hyperalgesia model in healthy volunteers.;Primary end point(s): Primary end points are areas of pin-prick hyperalgesia (260nM vonFrey filament) and areas of touch-evoked allodynia (stroking by cotton wool tip)	—

Measure

Time frame

Main Objective: To investigate the effects of intravenous paracetamol and tramadol on the areas of hyperalgesia and allodynia in an electrical hyperalgesia model in healthy volunteers.;Secondary Objective: To investigate the effects of intravenous paracetamol and tramadol on pain and flare in an electrical hyperalgesia model in healthy volunteers.;Primary end point(s): Primary end points are areas of pin-prick hyperalgesia (260nM vonFrey filament) and areas of touch-evoked allodynia (stroking by cotton wool tip)

—

Countries

Germany

Outcome results

None listed

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