Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-04-13 @ 8:33 AM
Study NCT ID:
NCT02596360
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hydex
Brief 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).
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).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003271-30 | REGISTRY | 2015-003271-30 | View |