Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain

This study is investigating a patch treatment called Qutenza for nerve pain that can develop after surgery. Researchers want to find out how effective Qutenza is at reducing this type of pain compared to a placebo (a dummy patch that contains no medicine). They will also be closely monitoring any side effects to understand its safety. Participants in the study, who must be 18 years or older, will receive either the Qutenza patch or the dummy patch. The main goal is to measure changes in a person's average pain over several weeks. This information will help doctors understand if Qutenza is a good treatment option for post-surgical nerve pain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Averitas Pharma Inc.

Enrolment target

204

Start

13 Aug 2024

Post-surgical neuropathic pain

What is this study about?

This study is all about helping people who suffer from nerve pain after surgery. Sometimes, after an operation, the nerves can get damaged or irritated, leading to a type of pain called neuropathic pain. This pain can feel like burning, shooting, or tingling. Doctors are looking at a treatment called Qutenza, which is a skin patch designed to help relieve this pain.

The main aim of the study is to see if Qutenza effectively reduces this pain. To do this fairly, some people will get the actual Qutenza patch, and others will get a 'dummy' patch, known as a placebo. This helps ensure that any improvements seen are truly due to the Qutenza patch and not just the expectation of feeling better. All participants will be over 18 years old.

Researchers will carefully track how much a person's pain changes over several weeks and months. They'll also record any side effects that might happen. By comparing the results from those who received Qutenza with those who received the dummy patch, the researchers can determine if Qutenza is a safe and effective treatment for nerve pain after surgery.

Key takeaways

This study is for adults with nerve pain after surgery.
It tests a pain patch called Qutenza against a dummy patch.
The main goal is to see if Qutenza reduces pain and is safe.
You won't know if you're getting the active patch or the dummy.
Your pain levels and any side effects will be closely monitored.
Participation involves regular visits over several months.

Who may be eligible?

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

The most important thing is that you have nerve pain that started after a surgery. The study is specifically looking for people with this type of pain to see if the treatment can help them.

There might be other health conditions or medications that could prevent someone from joining, but these will be checked carefully by the study doctors to make sure it's safe for you to take part.

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 experience nerve pain that started after a surgery?
Are you able to attend regular appointments for several months?
Are you comfortable not knowing if you're receiving the active treatment or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a check-up to see if you are suitable. If you are, you would be randomly assigned to receive either the Qutenza patch or a dummy patch. Neither you nor the study doctors would know which one you are getting, to keep the results fair.

The patches would be applied to the area where you experience pain. You would have regular appointments over several weeks and months. During these visits, you'd be asked about your pain levels, and doctors would check the size of the painful area and monitor for any side effects. These visits would involve discussions, pain assessments, and sometimes physical examinations. The total duration of your participation could extend for several months.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of improving your post-surgical nerve pain if the Qutenza patch works for you. You would also be contributing to medical knowledge that could help many others with similar conditions. However, there are potential risks, such as experiencing side effects from the patch, even if it's the dummy patch. You might not experience any pain relief. Remember, participation is completely voluntary, and you have the right 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
Netherlands
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Unverified
Spain
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Unverified
Poland
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Unverified
France

Common questions

What is post-surgical neuropathic pain?

It's a type of nerve pain that can develop after an operation, often feeling like burning, shooting, or tingling.

What is Qutenza?

Qutenza is a patch that delivers a medicine called capsaicin, which aims to reduce nerve pain.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're getting the active Qutenza patch or a dummy (placebo) patch.

Will I have to pay to be in the study?

No, you should not have to pay for any study-related treatments or visits.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without giving a reason, and it won't affect your future medical care.