Hyperalgesia Clinical Trial
— HydexOfficial title:
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy male volunteers - Aged between 18 and 45 years - CYP2D6 Extensive and Intermediate metabolizers - Body mass index (BMI) between 19 and 30 kg/m2 - Systolic blood pressure between 100 and 150 mmHg, diastolic blood pressure between 50 and 90 mmHg, heart rate between 45 and 90 beats per minute - Without treatment during the 7 days before inclusion specially no use of analgesic and anti-inflammatory drugs - Cooperation and understanding enough to conform to the study obligations - Having given free informed written consent - Affiliated to the French Social Security - Inscription or acceptation of inscription in the national register of volunteers involved in trials. Exclusion Criteria: - Hypersensitivity to the active substance or to any of the excipients - Lactose intolerance - Hypertension - History of stroke - Severe heart failure - Severe hepatic impairment - Shortness of breath - Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency - Association with linezolid - Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy - Diabetes (type I and II) - CYP2D6 Poor and Ultra-rapid metabolizers - AST, ALT, total bilirubin twice the average - Dextromethorphan intake during the 7 days before inclusion - Medical and surgical history incompatible with the study - Disease progression during inclusion - Excessive consumption of alcohol (> 50g/day), tobacco (= 10 cigarettes/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cups a day) or any addiction to drugs - Subject lacking concentration during tests training and low test results reproducibility - Subject does not meet the selection criteria for its ability to discriminate sensations to noxious stimuli during psychometric tests - Subject exclusion period, or the total allowable compensation exceeded - Subject undergoing a measure of legal protection (guardianship, supervision |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | No | |
Secondary | 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 | No | |
Secondary | Percentage changes in mechanical pain thresholds (MPT) using electronic von frey in control skin zone (Z0) | 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). | No | |
Secondary | 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). | No | |
Secondary | Conditioned Pain Modulation (CPM) assessment | at Day -1 before treatment and Day 0 30 min before treatment (T0-30min) | No | |
Secondary | Reaction time assessment using RTI CANTAB® 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). | No | |
Secondary | 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). | No |
Secondary | Study of genetic polymorphism of cytochrome P450 3A4 and genetic polymorphism of MDR1 gene | up to 6 months. | No | |
Secondary | 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). | No |
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