A multicenter randomized, double-blind, placebo-controlled Phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP) / NEPTUNE-17.
This research study, called NEPTUNE-17, is looking into a new potential medicine named GSK3858279. It's for adults who have ongoing pain in their nerves, caused by diabetes. The main goal is to find out if this new medicine can help reduce how much pain people feel each day over 12 weeks. Researchers will also be checking if the medicine is safe and if there are any side effects. To make sure results are fair, some participants will receive the active medicine, while others will get a placebo (a harmless dummy treatment that looks the same). Researchers will also study how the medicine behaves in the body. This is a Phase 2 study, meaning it's an early stage of testing new treatments.
At a glance
What is this study about?
If you have diabetes, you might experience a long-term type of nerve pain, often in your hands, feet, arms, or legs. This is known as Diabetic Peripheral Neuropathic Pain (DPNP), and it can significantly impact daily life. Doctors are always looking for better ways to manage this pain.
This study, called NEPTUNE-17, is testing a new medicine named GSK3858279. This medicine is designed specifically to help with this kind of nerve pain. The main purpose is to see if it can reduce the amount of pain people feel regularly. Researchers will also be checking carefully to see if the medicine is safe for people to take and if there are any unwanted side effects.
This is a 'Phase 2' study, which means it's an important step in developing new medicines. It's not yet approved for general use, but it helps doctors find out if it works well enough to be tested in larger studies later on. Your participation could help improve future treatments for DPNP.
Key takeaways
- This study is testing a new medicine for diabetes-related nerve pain.
- It aims to see if the medicine reduces pain and is safe.
- Some people will get the medicine, others a dummy treatment (placebo).
- Participation involves regular visits and health checks over 12 weeks.
- You can withdraw from the study at any time.
- It's an early-stage study to gather important information about the new treatment.
Who may be eligible?
This study is open to adults aged 18 years and older. Both men and women are welcome to take part.
To be considered for this study, you must have ongoing nerve pain due to your diabetes. The research team will need to check your medical history and current health to make sure you're a good fit for the study and that it's safe for you to participate.
There might be other specific health requirements or conditions that would mean you can't join, but the study team will discuss all of this with you if you're interested.
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 nerve pain because of your diabetes?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive a placebo?
- Have you discussed your interest with your regular doctor?
What does participation involve?
If you decide to take part in this study, you'll be assigned either the new medicine (GSK3858279) or a 'placebo', which is a dummy treatment that looks exactly like the real medicine but contains no active drug. Neither you nor your study doctor will know which one you are receiving – this is to ensure the results are as unbiased as possible.
Your participation will involve regular visits to the clinic over a period of 12 weeks. During these visits, the study team will: * Ask you about your pain levels using a simple rating scale. * Perform physical examinations. * Possibly take blood samples to check how the medicine is working and for safety. * Discuss any side effects you might be experiencing.
After the main 12-week treatment period, there will be some follow-up appointments to check on your well-being. The total duration of your involvement in the study, from start to finish, will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is Diabetic Peripheral Neuropathic Pain (DPNP)?
It's a type of long-lasting nerve pain caused by diabetes, often felt in the arms, hands, legs, or feet.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know during the study. This helps keep the results unbiased.
How long will I be in the study?
The main treatment part of the study lasts 12 weeks, with some follow-up appointments afterwards. The study team will give you exact timings.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, without losing access to your usual care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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