Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
NCT ID: NCT02596360
Last Updated: 2016-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2015-11-30
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
NCT01263652
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
NCT03927729
A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects
NCT04683926
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
NCT05170841
An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
NCT01112267
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dextromethorphan
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).
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).
Placebo
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).
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gisèle PICKERING
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003271-30
Identifier Type: REGISTRY
Identifier Source: secondary_id
CHU-0248
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.