All studies
AuthorisedTherapeutic use (Phase IV)Interventional

Pharmacokinetic study of the use of Nefopam 30 mg tablet in patients suffering from acute pain in rheumatology - NEFOPAIN kinetics

This research, called 'NEFOPAIN kinetics', is studying how a pain relief medicine called Nefopam behaves inside the bodies of hospital patients experiencing sudden, severe joint and muscle pain (rheumatological pain). The main goal is to understand how quickly the medicine gets into the body, how much of it reaches the bloodstream, how long it stays there, and how it leaves the body. Researchers are looking at both the tablet and injection forms of Nefopam. By understanding these actions, they hope to find the most effective and safest ways to use this medicine for pain, ensuring patients get the right amount at the right time. This is a later-stage study, checking the medicine's use in real-world situations.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Centre Hospitalier Universitaire Rouen
Enrolment target
29
Start
24 Sep 2025

What is this study about?

This study is designed to understand more about a pain medication called Nefopam when it's given to people who are in hospital with sudden, severe joint and muscle pain. Think of it like watching how a sip of water goes through your body – how long it takes to be absorbed, how much stays in your system, and how quickly it leaves. For medicines, this process is called pharmacokinetics. The researchers want to understand this journey for Nefopam in detail.

They'll be looking at specific things like how quickly the medicine reaches its highest level in the blood (Cmax), how long it takes to reach that peak (Tmax), and how much of the medicine overall is in the body over time (this is called exposure). They are also comparing the tablet form of Nefopam with the injectable form to see if they work similarly in your body, especially how much of the medicine actually gets into your system and can be used by your body – this is known as bioavailability.

Ultimately, the goal of this research is to gather important information that can help doctors decide on the best and most effective doses of Nefopam for patients with this type of pain. By understanding how the body processes the medication, they can make sure patients receive treatment that is both safe and works well. This is a crucial step in making sure medicines are used in the best possible way for patients in real-life hospital settings.

Key takeaways

  • This study helps understand how Nefopam, a pain medicine, works in the body.
  • It's for hospital patients with sudden, severe joint and muscle pain.
  • Researchers are comparing tablet and injection forms of the medicine.
  • The goal is to find the best ways to use Nefopam for pain relief.
  • You can be any adult age (18+) and either male or female.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate.

The study is specifically looking for people who are currently in hospital because of sudden and severe joint and muscle pain (this is often called acute rheumatological pain). You would also need to be someone for whom your doctors believe Nefopam might be a suitable pain relief option.

Simply put, if you're an adult in hospital with significant joint or muscle pain, and the doctors are thinking about giving you Nefopam for it, you might be a good fit for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you currently in the hospital?
  3. Are you experiencing sudden, significant joint or muscle pain?
  4. Has your doctor mentioned Nefopam as a possible treatment for your pain?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given Nefopam, either as a tablet or as an injection, as part of your pain treatment in the hospital. The study involves taking several blood samples over a period of time after you receive the medication. These samples help the researchers track how the medicine moves through your body. You would typically receive both the tablet and injection forms of Nefopam at different times to allow for comparison. The total duration of your participation would depend on your hospital stay and the specific schedule for taking the medication and blood samples, but it generally involves a focused period of observation while you are already admitted to the hospital.

Potential risks and benefits

Taking part in this study may offer a direct benefit if the Nefopam effectively manages your pain. More broadly, your participation helps doctors better understand how Nefopam works, which could improve pain treatment for many patients in the future. As with any medication, Nefopam can have side effects, and blood tests involve minor discomfort and a very small risk of bruising or infection. The study team will explain all known risks to you before you agree to participate, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is Nefopam?

Nefopam is a medicine used to treat pain. This study is looking at how it works in people with sudden joint and muscle pain.

Why is this study important?

It helps doctors understand how Nefopam moves through your body, so they can use it more effectively and safely for patients who need pain relief.

Will I have to pay to be in the study?

No, you will not have to pay to participate. All study-related medication and tests are covered by the research.

What kind of pain is the study looking at?

The study focuses on acute rheumatological pain, which means sudden, severe pain in your joints or muscles, often requiring a hospital stay.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.