A double-blind placebo-controlled two period crossover study of pregabalin and aprepitant 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

EUCTR2004-004953-24-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 therefore to investigate the effects of oral pregabalin and aprepitant on experimentally-induced central sensitization in the electrical hyperalgesia model, using dosing titration regimens utilised in the clinic. Furthermore, as a hypothesis-generating part of the study, we propose to investigate the effect of a COX-2 inhibitor parecoxib in combination with either aprepitant or pregabalin.

Interventions

Trade Name: Lyrica Product Name: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pregabalin Concentration unit: mg milligram(s) Concentration type: range Concentration number: 75-30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers (both male and female) will be recruited to the study, 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 chronic oral pregabalin and aprepitant on the areas of hyperalgesia and allodynia in the electrical hyperalgesia model in healthy volunteers.;Secondary Objective: To determine the effect of chronic oral pregabalin and aprepitant on pain and flare evoked by electrical stimulation in healthy volunteers; To investigate the effects of intravenous parecoxib on the pregabalin- and aprepitant-evoked modulation of the areas of hyperalgesia and allodynia;;Primary end point(s): Primary Area of pin-prick hyperalgesia (260 mN von Frey filament) Area of touch-evoked allodynia (stroking by cotton wool tip)	—

Measure

Time frame

Main Objective: To investigate the effects of chronic oral pregabalin and aprepitant on the areas of hyperalgesia and allodynia in the electrical hyperalgesia model in healthy volunteers.;Secondary Objective: To determine the effect of chronic oral pregabalin and aprepitant on pain and flare evoked by electrical stimulation in healthy volunteers; To investigate the effects of intravenous parecoxib on the pregabalin- and aprepitant-evoked modulation of the areas of hyperalgesia and allodynia;;Primary end point(s): Primary Area of pin-prick hyperalgesia (260 mN von Frey filament) Area of touch-evoked allodynia (stroking by cotton wool tip)

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Countries

Germany

Outcome results

None listed

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