Invasive VentilationPhase 2/3NCT07493785
Dexmedetomidine for Invasive Ventilation In the NEOnate
A Phase 2/3 study testing Dexmedetomidine Injectable Solution and Glucose 5% Injectable Solution in people with Invasive Ventilation and Infant Pain, run by Centre Hospitalier Intercommunal Creteil at 12 sites in France.
Trial summary
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain. Read more about this study
- Who is it for?
- Ages Up to 10 weeks
- Conditions the study is for
- Invasive Ventilation, Infant Pain, Infant Discomfort
- What is being tested?
- Dexmedetomidine Injectable Solution and Glucose 5% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Jan 2027to 1 Feb 2034
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Up to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with a gestational age at birth < 32 weeks of gestation and corrected gestational age < 32 weeks postmenstrual age
- Invasively ventilated with an expected or effective duration of ventilation > 24 hours at inclusion
- Under mechanical ventilation since less than 72 hours at inclusion
- With parental consent
- Affiliated to or benefiting from a social security system
Who cannot join
- Previous inclusion in this trial
- Participation in another trial including analgesics or sedatives
- Ongoing palliative care
- Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours
- Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg < postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg/kg/min, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml/kg) in the 6 previous hours
- Pulmonary hypertension requiring pharmacological treatment
Show all 10Show fewer
- Heart rate <100 bpm
- Hepatic impairment defined as alanine aminotransferase level > 2 x normal upper limit
- Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event
- Hypersensitivity to the active substance or to any of the excipients contained in the medicine
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites
CHU Brest - Hôpital Morvan
Brest, 29609
Jean Michel ROUE, PhD, jean-michel.roue@chu-brest.fr
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Manon TAUZIN, MD, 0157022000 ext. 8407, manon.tauzin@chicreteil.fr
CHU Grenoble Alpes
Grenoble, 38700
Marie CHEVALLIER, PhD, mchevallier3@chu-grenoble.fr
CHRU Lille
Lille, 59000
Riadh BOUKHRIS, MD, riadh.BOUKHRIS@chu-lille.fr
CHU Limoges
Limoges, 87042
Laure PONTHIER, PhD, laure.ponthier@chu-limoges.fr
CHU de Nantes
Nantes, 44000
Noura ZAYAT, MD, noura.zayat@chu-nantes.fr
CHU de Nice
Nice, 6200
Isabelle GUELLEC, PhD, guellec-renne.i@chu-nice.fr
AP-HP Hôpital Necker Enfants Malades
Paris, 75015
Elsa KERMORVANT, PhD, elsa.kermorvant@aphp.fr
Hôpital NOVO - Site de Pontoise
Pontoise, 95300
Suzanne BORRHOMEE, MD, suzanne.borrhomee@ght-novo.fr
Centre Hospitalier de Saint -Denis
Saint-Denis, 93200
Saba SALIBA, MD, saliba.saba@ch-stdenis.fr
CHU Félix Guyon (Saint Denis)
Saint-Denis, 97400
Anthony GRONDIN, MD, anthony.grondin@chu-reunion.fr
CHU de La Réunion - Site Sud Saint-Pierre
Saint-Pierre, 97400
Silvia IACOBELLI, PhD, silvia.iacobelli@chu-reunion.fr
About this study
Official title: Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.
As opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.
Read more
Although opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.
Dexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.
The investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Neonatal Respiratory Failure
- Being tested
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Keywords
- Neonatology, Invasive mechanical ventilation, Analgesia, Dexmedetomidine, Neurodevelopment, Opioids, Pain, Withdrawal syndrome
- Medical subject headings
- Agnosia, Pain, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injectable SolutionDrug
Intravenous administration for maximum 20 days
Glucose 5% Injectable SolutionDrug
Intravenous administration for maximum 20 days
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine Injectable Solution |
| Glucose 5% | Placebo comparator | Not described Receives: Drug: Glucose 5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Opioids used
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last.
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Secondary outcomes (30)
Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale
Scores of COMFORTneo scale :
- excessive: score <11
- appropriate: score between 11 to 13
- insufficient : score >13
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Duration of invasive ventilation in hours
Measured: From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours
Number of days with opioids and/or benzodiazepines
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Cumulative dose of midazolam or other benzodiazepines
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of days with paracetamol use
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of muscle blocker use to improve ventilation
Number of patients receiving muscle bocker
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Rate of extubation failure
Number of reintubation within 7 days after the first planned extubation
Measured: Within 7 days after the first planned extubation
Rate of unplanned extubation
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Age at full enteral feeding in postmenstrual age (weeks)
To respond to the secondary objective : frequency of opioid-related adverse effects
Measured: From inclusion to hospital discharge, assessed up to 24 weeks
Frequency of urinary retention episodes
To respond to the secondary objective : frequency of opioid-related adverse effects
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Finnegan neonatal withdrawal scale or any other validated withdrawal scale
To respond to the secondary objective : frequency of opioid-related adverse effects
Measured: Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours
Number of Bradycardia episodes
Heart rate < 100/min for 5 consecutive minutes
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of hypotension episodes
Mean arterial blood pressure in mmHg < postmenstrual age in weeks.
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of anti-hypotensive treatments use
Volume expansion (at least 10 ml/kg), dopamine, dobutamine, epinephrine, norepinephrine, milrinone or hydrocortisone for hemodynamic support.
Measured: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of In-hospital deaths
Measured: At 36 weeks postmenstrual age
Number of In-hospital deaths
Measured: From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of invasive ventilation
Number of days
Measured: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of non-invasive ventilation
Number of days
Measured: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of NICU stays
Number of days
Measured: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration Hospital stay
Number of days
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting high-grade intraventricular hemorrhage Grade 3 and 4
To respond secondary objective of neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting periventricular leukomalacia
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting secondary sepsis
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patientsTreated for patent ductus arteriosus
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting bronchopulmonary dysplasia
To respond secondary objective of severe neonatal morbidities
Measured: At 36 weeks postmenstrual age
Number of patients presenting necrotizing enterocolitis
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting isolated intestinal perforation
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting treated retinopathy of prematurity
To respond secondary objective of severe neonatal morbidities
Measured: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Long-term neurodevelopment using tests validated in French : Parent Report of Children's Abilities-Revised (PARCA-R)
Higher scores indicate improved neurodevelopment
Measured: At 2 years corrected age +/- 2 months
Long-term neurodevelopment using tests validated in French : BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery")
Higher scores indicate improved neurodevelopment
Measured: At age 6 years +/- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive VentilationStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, multicenter, randomized, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Xavier DURRMEYER
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493785
- Sponsor's protocol ID
- DIVINEO
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation
- ClinicalTrials.gov ID
- NCT07493785
- Acronym / sponsor ID
- DIVINEO
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Neonatal Respiratory Failure
- Keywords
- Neonatology, Invasive mechanical ventilation, Analgesia, Dexmedetomidine, Neurodevelopment, Opioids, Pain, Withdrawal syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Pr Xavier DURRMEYER
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 25 Mar 2026 (actual)
- 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.
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.
As opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.
Although opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.
Dexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.
The investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, multicenter, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine Injectable Solution |
| Glucose 5% | Placebo comparator | Drug: Glucose 5% Injectable Solution |
Who may qualify
- Ages
- Up to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates with a gestational age at birth < 32 weeks of gestation and corrected gestational age < 32 weeks postmenstrual age
- Invasively ventilated with an expected or effective duration of ventilation > 24 hours at inclusion
- Under mechanical ventilation since less than 72 hours at inclusion
- With parental consent
- Affiliated to or benefiting from a social security system
Key exclusion criteria (10 listed)
- Previous inclusion in this trial
- Participation in another trial including analgesics or sedatives
- Ongoing palliative care
- Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours
- Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg < postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg/kg/min, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml/kg) in the 6 previous hours
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 |
|---|---|---|
| Dexmedetomidine Injectable SolutionIntravenous administration for maximum 20 days | Drug | Dexmedetomidine |
| Glucose 5% Injectable SolutionIntravenous administration for maximum 20 days | Drug | Glucose 5% |
Primary outcome
Dose of Opioids used
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last.
30 secondary outcomes
Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Duration of invasive ventilation in hours
Time frame: From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours
Number of days with opioids and/or benzodiazepines
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Cumulative dose of midazolam or other benzodiazepines
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of days with paracetamol use
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of muscle blocker use to improve ventilation
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Rate of extubation failure
Time frame: Within 7 days after the first planned extubation
Rate of unplanned extubation
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Age at full enteral feeding in postmenstrual age (weeks)
Time frame: From inclusion to hospital discharge, assessed up to 24 weeks
Frequency of urinary retention episodes
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Finnegan neonatal withdrawal scale or any other validated withdrawal scale
Time frame: Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours
Number of Bradycardia episodes
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of hypotension episodes
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of anti-hypotensive treatments use
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of In-hospital deaths
Time frame: At 36 weeks postmenstrual age
Number of In-hospital deaths
Time frame: From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of invasive ventilation
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of non-invasive ventilation
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of NICU stays
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration Hospital stay
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting high-grade intraventricular hemorrhage Grade 3 and 4
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting periventricular leukomalacia
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting secondary sepsis
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patientsTreated for patent ductus arteriosus
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting bronchopulmonary dysplasia
Time frame: At 36 weeks postmenstrual age
Number of patients presenting necrotizing enterocolitis
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting isolated intestinal perforation
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting treated retinopathy of prematurity
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Long-term neurodevelopment using tests validated in French : Parent Report of Children's Abilities-Revised (PARCA-R)
Time frame: At 2 years corrected age +/- 2 months
Long-term neurodevelopment using tests validated in French : BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery")
Time frame: At age 6 years +/- 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine Injectable Solution and Glucose 5% Injectable Solution in people with Invasive Ventilation and Infant Pain, run by Centre Hospitalier Intercommunal Creteil at 12 sites 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 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 12 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier DURRMEYER, MD, PhD (0157023468, Durrmeyer.Xavier@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Opioids used (time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.