AuthorisedTherapeutic use (Phase IV)Interventional

F-puff_SE_2024

This study, called F-puff_SE_2024, is focused on pain management for adults aged 18 and older. It's looking at how two specific fentanyl injection medications, Fentanyl Kalceks and Fentanyl Sandoz (both 50 micrograms/ml), work when used in real-world healthcare settings. This isn't a brand new treatment; it's about understanding how well these existing medicines help people control their pain. The main goal is to see how many patients experience a good response to their pain treatment. This information helps doctors understand the best ways to provide pain relief.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

Start

22 Oct 2025

PAIN MANAGEMENT

What is this study about?

Imagine you're experiencing pain, and your doctor prescribes medication to help. This study, called F-puff_SE_2024, is all about understanding how well certain pain relief medicines work in everyday medical practice. Specifically, it's looking at two types of fentanyl injections – Fentanyl Kalceks and Fentanyl Sandoz, both at a strength of 50 micrograms/ml. These are not new medications; they are already used to help people manage pain. The study is a chance for doctors and researchers to gather more information about how effective these treatments are for patients like you.

The main thing researchers want to find out is how many people feel a real difference in their pain after using these medications. They'll be looking at something called a 'responder rate,' which simply means how many patients get good pain relief. This helps doctors confirm that the medications are working as expected and allows them to make informed decisions about prescribing the best pain management options.

This kind of study is important because it helps improve how we use existing medicines. By carefully looking at how these fentanyl injections are used in practice, and how patients respond, healthcare professionals can refine their approach to pain management, aiming to give patients the most effective care possible.

Key takeaways

Study examines existing fentanyl injections for pain relief.
Aims to understand how well these medications work in real-world use.
Looks at two specific fentanyl preparations: Kalceks and Sandoz.
Open to adults aged 18 and older, both men and women.
Helps improve future pain management strategies.
Participation fits within your usual medical care.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning any adult over 18 can be considered.

Both men and women are welcome to join this study. The researchers are interested in understanding how these pain medications affect everyone, regardless of their gender. You also need to be someone who is receiving or starting treatment with one of the specific fentanyl injections mentioned in the study for pain management as part of your regular care.

Ultimately, your doctor will be able to tell you if this study is a good fit for you based on your current health and pain treatment plan.

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.

Are you 18 years old or older?
Are you currently receiving or about to receive Fentanyl Kalceks or Fentanyl Sandoz injections for pain?
Are you able to speak with your doctor about your pain levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process would be quite straightforward as it looks at how treatments are used normally. You would be receiving one of the study medications (Fentanyl Kalceks or Fentanyl Sandoz) for your pain management as prescribed by your doctor, just like you would usually. The main part of your participation would involve assessments of your pain level. These assessments would help the researchers understand how well the medication is working for you. You would likely be asked to rate your pain on a simple numerical scale, known as the NPRS scale, at different times. The exact number of visits, duration of follow-up, and total time you participate would depend on your specific treatment plan and how long your doctor determines you need the medication. Since this is looking at treatments already in use, it aims to fit in with your existing treatment journey as much as possible.

Potential risks and benefits

Taking part in this study may offer some benefits, such as contributing to a better understanding of pain management, which could help future patients. Because this study involves medications already approved and in use, the risks are generally those already known and associated with Fentanyl injections. Your doctor will discuss the potential side effects, which can include drowsiness, nausea, or breathing changes. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Hungary

Common questions

What is fentanyl?

Fentanyl is a strong pain relief medicine, often used for severe pain. It's usually given by injection.

Why are there two different fentanyl names?

The study is looking at two versions of fentanyl made by different companies, but both at the same strength, to see how well they work in practice.

What does 'responder rate' mean?

It means how many people who take the medication experience a good level of pain relief. Researchers want to know this percentage.

Will I get a different treatment than my doctor recommends?

No, this study looks at how these medications are used in normal patient care. Your doctor will prescribe what's best for you, and if it's one of the study drugs, you might be able to participate.

Do I have to pay to be in the study?

No, you don't have to pay to participate in the study. Your standard NHS care costs remain the same.