NCT02596360

Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.

Detailed description

This is a cross-over group, double-blind, randomized clinical trial in healthy volunteers comparing dextromethorphan and inactive control on freeze-induced hyperalgesia, experimental pain, diffuse noxious inhibitory control (DNIC), pupillary reaction and reaction time. The influence of CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured. The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo). Each study sequence consists of 3 assessment days (Day -1, Day 0 = first treatment administration and Day 1).

Conditions

• Experimental Pain
• Hyperalgesia

Interventions

Type	Name	Description
DRUG	Pulmodexane® 30mg	The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).
DRUG	lactose	The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-11-04
• Last updated: 2016-04-01

Locations

1 site across 1 country: France