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Study comparing oral and injectable nefopam in patients with acute rheumatologic pain to evaluate how the medication is processed by the body

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with acute rheumatological pain who are being treated with Nefopam, a pain-relief medication. The study compares two different forms of the same medication: a tablet form (30 mg) taken by mouth and an injectable solution (20 mg) given through intravenous administration. The purpose is to understand how the body processes these two different forms of the medication.

During the study, participants who are hospitalized for rheumatological conditions will receive both forms of the medication at different times. The study will measure how the medication moves through the body and how well it is absorbed when given as a tablet compared to when it is given as an injection. This information will help determine the most effective way to give the medication to future patients.

The research will analyze several aspects of how the medication works in the body, including how long it takes to reach its highest level in the blood, how long it stays in the body, and how much of the medication becomes available for use. This information will help doctors better understand the differences between the tablet and injectable forms of Nefopam and potentially improve pain treatment for patients with rheumatological conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive Nefopam through an intravenous (into the vein) infusion at a dose of 20 mg/2 ml

    Blood samples will be collected to measure the medication levels in your body

  2. Step 2

    Transition period

    A brief waiting period will occur between the two forms of medication administration

  3. Step 3

    Oral medication phase

    You will take Nefopam in tablet form at a dose of 30 mg

    Additional blood samples will be collected to measure medication levels

  4. Step 4

    Monitoring period

    Your hospital stay must continue for at least 4 days

    Medical staff will monitor your pain levels using a numerical scale

    Regular assessments will continue throughout your hospital stay

  5. Step 5

    Study completion

    The study participation ends after the completion of all blood samples and monitoring period

    Your regular medical care will continue as prescribed by your healthcare team

Who can join the trial?

11 criteria

  • Must be hospitalized in the rheumatology department
  • Must be between 18 and 75 years old
  • Must have acute musculoskeletal pain (pain affecting muscles, bones, or joints)
  • Must have a planned hospital stay of at least 4 days
  • Must have a pain score of 3 or higher on the numerical scale
  • Must be enrolled in or eligible for social security benefits
  • Must have read and signed the informed consent form
  • For women who can have children:
    • Must use effective birth control methods for at least 4 weeks before joining the study, during treatment, and for 3 days after the last dose
    • Must have a negative pregnancy test at the start of the study
    • For women after menopause:
      • Must not have had menstrual periods for at least 12 months
      • May need hormone tests to confirm menopausal status if not using hormone treatments

Who cannot join the trial?

15 criteria

  • Known allergic reactions to nefopam or any components of the medication
  • Severe kidney problems (impaired renal function)
  • Severe liver disease that affects liver function
  • Convulsive disorders (conditions that cause seizures)
  • Urinary retention (inability to fully empty the bladder)
  • Risk of angle-closure glaucoma (increased pressure in the eye)
  • Current or recent use of MAO inhibitors (certain antidepressant medications)
  • Pregnant or breastfeeding women
  • History of substance abuse or drug addiction
  • Participation in another clinical trial within the past 30 days
  • Unable to provide informed consent
  • Serious heart conditions or uncontrolled high blood pressure
  • Active mental health conditions that could interfere with the study
  • Taking medications that could interact with the study drug
  • History of severe adverse reactions to similar pain medications
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Investigated drugs

Nefopam is a pain-relieving medication used to treat moderate to severe acute pain. It works differently from opioids and NSAIDs, helping to control pain by affecting the way the brain processes pain signals. This medication is particularly useful in treating acute pain conditions in rheumatology, such as joint or muscle pain. It is available in both tablet and injectable forms, and it can provide effective pain relief while having a different side effect profile compared to other common pain medications.

What is already known about the treatment

Nefopam - A centrally-acting non-opioid analgesic medication available in both oral tablet (30 mg) and injectable solution (20mg/2mL) forms, used primarily for the treatment of acute pain, particularly in rheumatological conditions. The drug works by inhibiting the reuptake of serotonin, norepinephrine, and dopamine in the central nervous system, providing pain relief through multiple mechanisms without the respiratory depression associated with opioids. As a non-opioid analgesic, it serves as an important alternative for pain management in hospitalized patients, particularly when traditional painkillers are contraindicated or insufficient, and its pharmacokinetic profile is currently being studied to optimize its clinical use in acute pain management.

Investigated diseases

Acute Rheumatological Pain - A severe form of pain that affects joints, muscles, and surrounding tissues due to rheumatological conditions. The pain typically develops rapidly and can significantly impact mobility and daily activities. It involves inflammation of joints and connective tissues, which can cause swelling, stiffness, and tenderness. The condition may affect single or multiple joints simultaneously, and the intensity of pain can vary throughout the day.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521926-13-00Protocol code2022/0355/HPEstimated enrolment29 patientsSponsorCentre Hospitalier Universitaire Rouen

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