Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and tolerability of ODM-111 in chronic pain due to diabetic peripheral neuropathy

This research trial is testing a new medicine, ODM-111, for people who experience ongoing pain because of diabetic peripheral neuropathy. This is a condition where high blood sugar damages nerves, often in the feet and hands, leading to persistent pain. The study is in an early phase (Phase II), meaning we're exploring how effective the medicine is and if it causes any side effects. We'll be comparing ODM-111 to other treatments, including a placebo (a dummy pill containing no medicine), and a common pain reliever called Para-Tabs. The main goal is to see if ODM-111 can make a real difference in reducing daily pain levels over a six-week period. Participants will simply need to record their pain each day.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Orion Corporation

Enrolment target

203

Start

21 Oct 2024

CHRONIC PAIN DUE TO DIABETIC PERIPHERAL NEUROPATHY

What is this study about?

If you live with diabetes, you might be familiar with a condition called diabetic peripheral neuropathy. This is when high blood sugar levels over time damage your nerves, most commonly in your hands and feet. This damage can lead to a type of ongoing, stubborn pain that can be difficult to manage and can significantly affect your daily life.

This study is an important step in finding new ways to help people like you. We are looking at a new medicine, called ODM-111, to see if it can safely and effectively reduce this chronic pain. We want to understand if it works better than existing treatments or a dummy pill (placebo).

By taking part, you would be helping researchers learn more about how to treat this specific type of pain. This knowledge could lead to new and better options for many people living with diabetic pain in the future.

Key takeaways

New medicine (ODM-111) being tested for diabetic nerve pain.
Compares ODM-111 to a dummy pill and common pain relief.
Mainly involves taking medicine and recording daily pain.
Study lasts for at least 6 weeks, plus other visits.
Helps researchers find better pain treatments for the future.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages are welcome to consider taking part.

This study is specifically for people who have ongoing pain caused by diabetic peripheral neuropathy. This means your pain must be linked to your diabetes affecting your nerves.

Both men and women are invited to participate in this research. We want to include a wide range of people to make sure the results are as helpful as possible for everyone affected by this condition.

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 ongoing pain caused by diabetes affecting your nerves?
Are you able to attend study appointments regularly?
Would you be comfortable recording your pain daily in a diary?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be trying out one of three types of treatment: the new medicine ODM-111, a harmless dummy pill (placebo), or Para-Tabs 500 mg. Which one you receive would be decided by chance, like flipping a coin. You wouldn't know which one you're taking, and neither would your study doctor.

The main part of the study involves taking your assigned medicine and keeping a simple daily diary on an electronic device (eDiary). In this diary, you would record your pain levels each day for six weeks. This helps us understand if the medicine is making a difference.

There would likely be regular visits to the clinic for check-ups, where doctors and nurses would monitor your health, ask about your pain, and check for any side effects. The total duration of your involvement would be explained in full detail by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment before it's widely available, and close monitoring of your health. However, there are also potential risks, including side effects from the study medication, which will be fully explained to you. It's important to remember that you can stop participating at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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
Czechia
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Hungary

Common questions

What is diabetic peripheral neuropathy pain?

It's a long-lasting pain that happens when high blood sugar from diabetes damages nerves, often in the feet and hands.

What is ODM-111?

It's a new medicine being tested to see if it can help reduce chronic pain caused by diabetic peripheral neuropathy.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but contains no active ingredients. It helps us see if the new medicine works better than no treatment.

How long will I be in the study?

The main treatment period involves recording your pain daily for six weeks, but the total time you spend in the study will be longer and explained by the study team.

Can I leave the study if I want to?

Yes, you are always free to leave the study at any time, for any reason, without affecting your medical care.