Experimental PainPhase 1HydexNCT02596360
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
A Phase 1 study testing Pulmodexane® 30mg and lactose in people with Experimental Pain and Hyperalgesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Experimental Pain, Hyperalgesia
- What is being tested?
- Pulmodexane® 30mg and lactose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients
- Lactose intolerance
- Hypertension
- History of stroke
- Severe heart failure
- Severe hepatic impairment
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.
Read the 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
- Being tested
- Pulmodexane® 30mg, lactose
- Keywords
- Antinociception, Freeze-induced hyperalgesia model, Dextromethorphan, NMDA-receptors, Pharmacogenetic, CYP3A4 gene, MDR1 gene
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmodexane® 30mgDrug
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).
lactoseDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Pulmodexane® 30mg |
| 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). Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of percentage changes in mechanical pain thresholds (MPT) using electronic von frey in secondary hyperalgesic zone (Z2)
Measured: 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).
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: at Day -1 before treatment and Day 0 30 min before treatment (T0-30min)
Reaction time assessment using RTI CANTAB® test
Measured: 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.
Measured: 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
Measured: up to 6 months.
Dosage of plasma concentration of dextromethorphan and dextromethorphan's metabolites from blood collections
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Experimental PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596360
- Sponsor's protocol ID
- CHU-0248
- Other IDs
- 2015-003271-30, 2015
- Acronym
- Hydex
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2015
- Last updated
- 6 Aug 2026
- Results posted
- No
Publications
Martin E, Narjoz C, Decleves X, Labat L, Lambert C, Loriot MA, Ducheix G, Duale C, Pereira B, Pickering G. Dextromethorphan Analgesia in a Human Experimental Model of Hyperalgesia. Anesthesiology. 2019 Aug;131(2):356-368. doi: 10.1097/ALN.0000000000002736.
PubMed 31094746
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02596360
- Acronym / sponsor ID
- Hydex / CHU-0248
- Conditions
- Experimental Pain, Hyperalgesia
- Keywords
- Antinociception, Freeze-induced hyperalgesia model, Dextromethorphan, NMDA-receptors, Pharmacogenetic, CYP3A4 gene, MDR1 gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan | Experimental | Drug: Pulmodexane® 30mgThe 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 | Drug: lactoseThe 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- Hypersensitivity to the active substance or to any of the excipients
- Lactose intolerance
- Hypertension
- History of stroke
- Severe heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmodexane® 30mgThe 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 | Dextromethorphan |
| lactoseThe 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 | Placebo |
Primary outcome
Area under the curve (AUC) of percentage changes in mechanical pain thresholds (MPT) using electronic von frey in secondary hyperalgesic zone (Z2)
Time frame: 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).
8 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: at Day -1 before treatment and Day 0 30 min before treatment (T0-30min)
Reaction time assessment using RTI CANTAB® test
Time frame: 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
Time frame: 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
Time frame: up to 6 months.
Dosage of plasma concentration of dextromethorphan and dextromethorphan's metabolites from blood collections
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 31094746Martin E, Narjoz C, Decleves X, Labat L, Lambert C, Loriot MA, Ducheix G, Duale C, Pereira B, Pickering G. Dextromethorphan Analgesia in a Human Experimental Model of Hyperalgesia. Anesthesiology. 2019 Aug;131(2):356-368. doi: 10.1097/ALN.0000000000002736.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pulmodexane® 30mg and lactose in people with Experimental Pain and Hyperalgesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of percentage changes in mechanical pain thresholds (MPT) using electronic von frey in secondary hyperalgesic zone (Z2) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.