Acute Rheumatic PainPhase 4NEFOPAIN kinetNCT07491393
Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology
A Phase 4 study testing Nefopam administration and prelevment in people with Acute Rheumatic Pain, run by University Hospital, Rouen at 1 site in France.
Trial summary
Nefopam is a non-opioid analgesic approved for the symptomatic treatment of acute pain, particularly postoperative pain. The HAS has authorized nefopam tablet, while emphasizing the lack of bibliographic data on both the pharmacokinetic and clinical aspects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Rheumatic Pain
- What is being tested?
- Nefopam administration and prelevment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 7 Apr 2027
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized in rheumatology,
- Patient presenting with acute pain in the musculoskeletal system,
- Expected remaining length of hospital stay ≥ 4 days,
- EN ≥ 3
- Age ≥ 18 and ≤ 75,
- Patient who has read and understood the information letter and signed the consent form
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- Women:
- Of childbearing age, defined by the CTCG as fertile women, after menarche and until menopause, except in cases of permanent infertility (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- using highly effective contraception according to the CTCG (combined hormonal contraception (estrogen and progesterone) associated with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) associated with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) for at least 4 weeks prior to inclusion, during treatment, and up to 3 days after the last dose/administration of treatment,
- and having a negative urinary pregnancy test for β-HCG at inclusion.
- Postmenopausal: Menopause is defined by the CTCG as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the postmenopausal interval can be used to confirm postmenopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Patient affiliated with a social security system or beneficiary of such a system.
Who cannot join
- Patients who have received nefopam within 7 days prior to inclusion
- Patients with creatinine clearance ≤ 30 mL/min according to the CKD-EPI formula
- Severe or uncontrolled cardiovascular disease. Patients treated with enzyme-inducing or enzyme-inhibiting drugs (amiodarone, bupropion, fluoxetine, paroxetine, quinidine, venlafaxine, haloperidol, imipramine, tamoxifen, ketoconazole, ritonavir, clarithromycin, Carbamazepine, St. John's Wort, Itraconazole, Rifampicin, Dexamethasone)
- Patients treated with medication(s) containing alcohol as an excipient.
- Patients with severe hepatic impairment (ASAT and/or ALAT > 5 times the upper normal limit).
- History of psychological or sensory disease or abnormality that may prevent the subject from fully understanding the conditions required for participation in the protocol or prevent them from giving informed consent.
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- Patients unable to understand pain scales.
- Medical contraindications for NEFOPAM VIATRIS 20 mg/2 mL, injectable solution, or NEFOPAM PANPHARMA 30 mg, film-coated tablet:
- Hypersensitivity to nefopam or any of the excipients.
- Convulsions or history of convulsive disorders.
- Risk of urinary retention associated with urethroprostatic disorders.
- Risk of angle-closure glaucoma.
- Patients suffering from constipation.
- Patients with a history of disorders associated with the use of psychoactive substances.
- Pregnant women, women in labor, breastfeeding women, or women who are not using effective contraception.
- Persons deprived of their liberty by administrative or judicial decision or persons placed under judicial protection/guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armelle Guidotti contact
France1 site
CHU de ROUEN
Rouen
Sophie Pouplin, MD, +332 32 88 92 21, sophie.pouplin@chu-rouen.fr
About this study
Nefopam is a non-opioid analgesic approved for the symptomatic treatment of acute pain, particularly postoperative pain. The HAS has authorized nefopam tablet, while emphasizing the lack of bibliographic data on both the pharmacokinetic and clinical aspects.
The aim of this study is to evaluate the pharmacokinetics of nefopam tablets.
- Conditions
- Acute Rheumatic Pain
- Being tested
- Nefopam administration and prelevment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nefopam administration and prelevmentDrug
Catheter placement, blood samples taken from H0 to H12 after each dose of nefopam in 4mL lithium heparin tubes without separating gel (9 samples per dose of nefopam)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 : IV then tablet form | Other | administration of Nefopam IV (H0) - washout (H0 à H72) -nefopam tablet administration (H72) Receives: Drug: Nefopam administration and prelevment |
| Sequence 2 : tablet then IV form | Other | administration of Nefopam tablet administration (H0) - washout (H0 à H72) -nefopam IV administration (H72) Receives: Drug: Nefopam administration and prelevment |
What is being measured
The primary outcome is the main question the study is designed to answer.
terminal elimination half-life
terminal elimination half-life
Measured: 6 days
Cmax
Peak plasma concentration
Measured: 6 days
Tmax
time to maximum concentration
Measured: 6 days
exposure
characterized by the area under the curve obtained using the trapezoidal method
Measured: 6 days
bioavailability
bioavailability will be calculated using the ratio of AUCs between the oral and intravenous forms
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Rheumatic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491393
- Sponsor's protocol ID
- 2022/0355/HP
- Other IDs
- 2025-521926-13-00, 2025
- Acronym
- NEFOPAIN kinet
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology
- ClinicalTrials.gov ID
- NCT07491393
- Acronym / sponsor ID
- NEFOPAIN kinet / 2022/0355/HP
- Conditions
- Acute Rheumatic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 24 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.
Nefopam is a non-opioid analgesic approved for the symptomatic treatment of acute pain, particularly postoperative pain. The HAS has authorized nefopam tablet, while emphasizing the lack of bibliographic data on both the pharmacokinetic and clinical aspects.
The aim of this study is to evaluate the pharmacokinetics of nefopam tablets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 : IV then tablet form | Other | Drug: Nefopam administration and prelevmentadministration of Nefopam IV (H0) - washout (H0 à H72) -nefopam tablet administration (H72) |
| Sequence 2 : tablet then IV form | Other | Drug: Nefopam administration and prelevmentadministration of Nefopam tablet administration (H0) - washout (H0 à H72) -nefopam IV administration (H72) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient hospitalized in rheumatology,
- Patient presenting with acute pain in the musculoskeletal system,
- Expected remaining length of hospital stay ≥ 4 days,
- EN ≥ 3
- Age ≥ 18 and ≤ 75,
Key exclusion criteria (16 listed)
- Patients who have received nefopam within 7 days prior to inclusion
- Patients with creatinine clearance ≤ 30 mL/min according to the CKD-EPI formula
- Severe or uncontrolled cardiovascular disease. Patients treated with enzyme-inducing or enzyme-inhibiting drugs (amiodarone, bupropion, fluoxetine, paroxetine, quinidine, venlafaxine, haloperidol, imipramine, tamoxifen, ketoconazole, ritonavir, clarithromycin, Carbamazepine, St. John's Wort, Itraconazole, Rifampicin, Dexamethasone)
- Patients treated with medication(s) containing alcohol as an excipient.
- Patients with severe hepatic impairment (ASAT and/or ALAT > 5 times the upper normal limit).
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 |
|---|---|---|
| Nefopam administration and prelevmentCatheter placement, blood samples taken from H0 to H12 after each dose of nefopam in 4mL lithium heparin tubes without separating gel (9 samples per dose of nefopam) | Drug | Sequence 1 : IV then tablet form, Sequence 2 : tablet then IV form |
Primary outcome
terminal elimination half-life
Time frame: 6 days
terminal elimination half-life
Cmax
Time frame: 6 days
Peak plasma concentration
Tmax
Time frame: 6 days
time to maximum concentration
exposure
Time frame: 6 days
characterized by the area under the curve obtained using the trapezoidal method
bioavailability
Time frame: 6 days
bioavailability will be calculated using the ratio of AUCs between the oral and intravenous forms
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Armelle Guidotti contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nefopam administration and prelevment in people with Acute Rheumatic Pain, run by University Hospital, Rouen 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 12 inclusion and 16 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 24 Mar 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Sophie Pouplin, MD (+332 32 88 92 21, sophie.pouplin@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
terminal elimination half-life (time frame: 6 days). The study lists 5 primary outcomes in all. 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 24 Mar 2026.