AuthorisedTherapeutic confirmatory (Phase III)Interventional

A randomized, open-label, Phase III trial to assess the efficacy and safety of BupiZenge compared to lidocaine for pain associated with oral mucositis in head and neck cancer

This research is testing a new type of lozenge, called BupiZenge, to help with mouth sores and pain (oral mucositis) that can happen if you're being treated for head and neck cancer. When you have radiotherapy for cancer in this area, it can often lead to painful sores inside your mouth and throat. The study wants to find out if BupiZenge is more effective at reducing this pain compared to the usual treatment, which is lidocaine. Researchers will also be checking how safe BupiZenge is and if it causes any unwanted side effects. This is a "Phase III" trial, which means it's a big study designed to confirm if a new treatment works better than existing ones.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

OncoZenge AB

Enrolment target

150

Start

28 Apr 2026

Head and neck cancer, Oral mucositis

What is this study about?

If you're undergoing treatment for head and neck cancer, you might experience a very uncomfortable side effect called oral mucositis. This means you can develop painful sores and inflammation inside your mouth and throat, which can make eating, drinking, and even talking very difficult. This study is looking for better ways to manage this pain.

Researchers are comparing a new treatment, a lozenge called BupiZenge, with a common medicine already used for pain relief, called lidocaine. They want to see if BupiZenge can help reduce the pain more effectively and make it easier for people to cope with their cancer treatment. This is a very important type of study, known as a Phase III trial, which means it's one of the final stages of testing a new medicine before it might become widely available.

The main goal is to measure how much pain is reduced over time after taking one of these medicines. They'll also be looking at how many people feel a significant improvement in their pain. On top of checking if the new medicine works, the study will also carefully watch for any side effects to make sure it's safe to use.

Key takeaways

The study is investigating a new lozenge, BupiZenge, for mouth pain from cancer treatment.
It's comparing BupiZenge to a standard pain relief medicine, lidocaine.
The focus is on pain caused by oral mucositis in people with head and neck cancer.
Researchers will measure how well the medicines reduce pain and if they are safe.
This is a large, advanced study (Phase III) to confirm treatment effectiveness.
Participants will report pain and undergo clinic check-ups regularly.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would be considered if you have head and neck cancer and are experiencing pain from oral mucositis, which are the painful sores that can develop in your mouth during your cancer treatment, especially if you are having radiotherapy.

There might be other specific health requirements or conditions that mean you can or cannot take part, but these details would be discussed with you by the study team.

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?
Do you have head and neck cancer?
Are you experiencing painful mouth sores (oral mucositis) from your treatment?
Are you currently receiving or have recently received radiotherapy?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the new BupiZenge lozenge or the standard lidocaine treatment. You would be asked to use the medicine as instructed and regularly report on your pain levels. This would involve answering questions about your pain intensity both at home and when you visit the study site.

Throughout the study, you would have regular visits to the study clinic where nurses or doctors would check on your health and any side effects. These checks might include blood tests, weighing you, and checking your vital signs like blood pressure and pulse. The study will monitor your pain relief from the medicine, particularly within the first three hours after taking it, and track changes in your pain over several weeks, especially during and after radiotherapy.

The study will involve monitoring you for several weeks, specifically during your radiotherapy and for a few weeks afterwards. The total duration of your participation, including follow-up checks for safety, would be explained fully by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you better pain relief from oral mucositis, which might improve your quality of life during your cancer treatment. However, as with any medical treatment, there's always a chance of side effects, both known and unknown. The study team will carefully monitor you for any unwanted effects and will explain these to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Denmark
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Unverified
Norway
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Unverified
Sweden

Common questions

What is oral mucositis?

Oral mucositis is a common and often painful side effect of cancer treatment, especially radiotherapy for head and neck cancer. It causes sores and inflammation inside your mouth and throat, making it hard to eat and drink.

What is BupiZenge?

BupiZenge is a new type of lozenge being tested in this study. It's designed to help relieve the pain caused by oral mucositis.

Why is this study important?

This study aims to find a more effective way to manage the pain of oral mucositis, which can significantly improve comfort and quality of life for people with head and neck cancer during their treatment.

Will I know if I'm getting BupiZenge or lidocaine?

No, this is an "open-label" study, meaning both you and your study doctor will know whether you are receiving BupiZenge or lidocaine.

What will happen if I join the study?

You'll be given either BupiZenge or lidocaine, and you'll regularly report your pain levels. You'll also have clinic visits for health checks and to monitor any side effects.