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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003271-30 | Registry Identifier | 2015-003271-30 |
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The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextromethorphan | Experimental | 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). |
|
| Placebo | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulmodexaneĀ® 30mg | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of percentage changes in mechanical pain thresholds (MPT) using electronic von frey in secondary hyperalgesic zone (Z2) | at Day 0 after treatment administration: 1 hour post-dose (T0+1h), 2 hours post-dose (T0+2h) and 3 hours post-dose (T0+3h). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of percentage changes in mechanical pain thresholds (MPT) using electronic von frey in control skin zone (Z0) and primary hyperalgesic zone (Z1) | at D0 T0+1h, T0+2h and T0+3h after treatment administration | |
| Percentage changes in mechanical pain thresholds (MPT) using electronic von frey in control skin zone (Z0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GisĆØle PICKERING | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| lactose | Drug | 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). |
|
| at Day 0 after treatment administration: 1 hour post-dose (T0+1h), 2 hours post-dose (T0+2h) and 3 hours post-dose (T0+3h). |
| Percentage changes in mechanical pain thresholds (MPT) using electronic von frey in primary hyperalgesic zone (Z1) | at Day 0 30 min before treatment (T0-30min ) and at Day 0 after treatment administration: 1 hour post-dose (T0+1h), 2 hours post-dose (T0+2h) and 3 hours post-dose (T0+3h) and at Day 1 after treatment administration: 24,5 hours post-dose (T0+24h30). |
| Conditioned Pain Modulation (CPM) assessment | at Day -1 before treatment and Day 0 30 min before treatment (T0-30min) |
| Reaction time assessment using RTI CANTABĀ® test | at Day -1 before treatment and Day 0 30 min before treatment (T0-30min), after treatment administration: 1 hour post-dose (T0+1h) and 3 hours post-dose (T0+3h) and at Day 1 after treatment administration: 24,5 hours post-dose (T0+24h30). |
| Determination of potential central effects of dextromethorphan measuring pupillary reaction | Determination of potential central effects of dextromethorphan measuring pupillary reaction assessing the diameter of the pupil in real time in scotopic conditions (e.g. size variation [mm]; contraction speed [mm.s-1]; contraction latency [ms]) at Day 0 30 min before treatment (T0-30min ) and at Day 0 after treatment administration: 1 hour post-dose (T0+1h), 2 hours post-dose (T0+2h) and 3 hours post-dose (T0+3h) and at Day 1 after treatment administration: 24,5 hours post-dose (T0+24h30). - Study of genetic polymorphism of cytochrome P450 3A4 and MDR1 gene through study completion, up to 6 months. | at Day 0 30 min before treatment (T0-30min ) and at Day 0 after treatment administration: 1 hour post-dose (T0+1h), 2 hours post-dose (T0+2h) and 3 hours post-dose (T0+3h) and at Day 1 after treatment administration: 24,5 hours post-dose (T0+24h30). |
| Study of genetic polymorphism of cytochrome P450 3A4 and genetic polymorphism of MDR1 gene | up to 6 months. |
| Dosage of plasma concentration of dextromethorphan and dextromethorphan's metabolites from blood collections | at Day 0 30 min before treatment (T0-30min ) and at Day 0 after treatment administration: 2 hours post-dose (T0+2h) and at Day 1 after treatment administration: 24,5 hours post-dose (T0+24h30). |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |