A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of iN1011-N17-02 in Patients with Post herpetic Neuralgia (PHN)
This research is looking into a new medicine, iN1011-N17-02, for people who have ongoing nerve pain after having shingles, called post-herpetic neuralgia. It's a 'Phase 2' study, meaning it's still in the earlier stages of testing. Researchers want to find out if the new medicine is safe, what side effects it might have, and if it helps to ease the pain. They will also look at how the body handles the medicine. The study will compare it against a placebo (a dummy pill) and other common pain relief like paracetamol or Doreta. Participants will be randomly assigned to receive one of these options, and neither they nor the doctors will know which treatment they are getting.
At a glance
What is this study about?
This study is a medical trial exploring a new potential treatment, called iN1011-N17-02, for a condition known as post-herpetic neuralgia (PHN). PHN is a long-lasting nerve pain that can develop in some people after they've had shingles. Living with PHN can be very challenging, and researchers are constantly looking for more effective ways to help manage this complex pain.
The main goal of this particular study is to see if iN1011-N17-02 is safe to use and whether it can help to reduce PHN pain. It's a "Phase 2" study, which means it's an important early step in testing new medicines. We're also trying to find the best dose of the medicine and understand how it works in the body.
To make sure the results are reliable, the study is "randomised" and "double-blind." This means that participants will be put into different groups by chance, and neither you nor your study doctor will know whether you're getting the new medicine, a dummy pill (placebo), or other standard pain medications like paracetamol or Doreta. This helps us objectively see if the new medicine is genuinely helping. We'll be closely monitoring pain levels and any side effects throughout the study.
Key takeaways
- Tests a new medicine for long-lasting nerve pain after shingles.
- Compares the new medicine with a dummy pill and other pain relief.
- Main aim is to check safety and how well it reduces pain.
- Participants won't know which treatment they are receiving.
- Involves regular pain tracking, clinic visits, and medical tests for about 4 weeks.
- You can leave the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old – there's no upper age limit. Both men and women are welcome to take part.
Since this study focuses on post-herpetic neuralgia (PHN), you would need to have received a medical diagnosis of this condition. The study is specifically looking for people who are experiencing ongoing pain after a shingles outbreak.
There might be other specific health requirements or conditions that could prevent someone from joining, even if they have PHN, to ensure the study is safe for everyone involved. 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?
- Have you been diagnosed by a doctor with post-herpetic neuralgia?
- Are you able to attend regular clinic appointments?
- Are you comfortable with the possibility of receiving a dummy pill?
- Are you willing to keep a daily record of your pain levels?
What does participation involve?
If you decide to take part, you would receive either the new study medicine, a dummy pill, paracetamol, or Doreta. You wouldn't know which one you're getting. Your main task will be to keep track of your pain levels regularly, often using a simple scale (like 0 to 10) to describe how much pain you're feeling each day. This is usually done over 4 weeks.
You'll have several visits to the clinic for check-ups. During these visits, doctors and nurses will monitor your health, take your blood pressure, measure your pulse, check your temperature and breathing, and perform a physical examination. You might also have blood and urine tests, and an electrocardiogram (ECG) to check your heart. Some of these tests are to make sure the medicine is safe for you, and others are to see how it's affecting your body and pain.
You'll also fill out questionnaires about your pain and how it affects your daily life, including your sleep. There will be assessments to check how the medicine is processed by your body. The total duration of the medicine-taking part is 4 weeks, but there might be follow-up checks after that time.
Potential risks and benefits
Locations (2)
- —UnverifiedPoland
- —UnverifiedBulgaria
Common questions
What is post-herpetic neuralgia (PHN)?
PHN is a type of long-lasting nerve pain that can happen after someone has had shingles. It can be very uncomfortable and affect daily life.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the new medicine, a dummy pill, or another pain treatment. This helps make the study results fair.
Will I definitely get the new medicine?
Not necessarily. You will be randomly assigned to one of several groups. You could receive the new medicine, a dummy pill (placebo), or other standard pain relief like paracetamol or Doreta.
How long will I be taking part in the study?
The main treatment period for taking the medicine is about 4 weeks. There might be some follow-up appointments after that.
Can I stop participating if I want to?
Yes, absolutely. You have the right to leave the study at any time, for any reason, without this affecting your ongoing medical 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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