Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Simvastatin in the Prevention of Recurrent Pancreatitis, a Triple Blind, Randomized Controlled Trial.

This research is investigating if a widely used medication, simvastatin, can prevent repeat attacks of pancreatitis. Pancreatitis is a condition where the pancreas, an organ important for digestion, becomes inflamed. Patients who have had pancreatitis before are at risk of it returning, which can be painful and lead to further health problems. This study is testing whether taking simvastatin can lower the chances of these repeat episodes. It's designed to be a very fair test, where neither the patients, doctors, nor researchers know who is getting the simvastatin and who is getting a dummy pill (lactose monohydrate). The main goal is to see if simvastatin stops pancreatitis from coming back, and they'll also look at things like new diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital General Universitario Dr. Balmis

Enrolment target

144

Start

25 Sep 2024

Recurrent pancreatitis

What is this study about?

This study is designed to find out if a commonly prescribed medicine called simvastatin can help people who have had pancreatitis before to avoid getting it again. Pancreatitis is a condition where your pancreas gets inflamed. The pancreas is an important organ located behind your stomach that helps you digest food and control blood sugar. When it becomes inflamed, it can cause severe belly pain and other health issues.

For many people, pancreatitis can come back, which is called recurrent pancreatitis. This can be very painful and disruptive to daily life. Simvastatin is a medicine often used to lower cholesterol. However, some early research suggests it might also have properties that could reduce inflammation, which is why researchers are interested in whether it could help prevent pancreatitis from returning.

This is a 'Phase IV' study, which means the medicine (simvastatin) is already approved and used for other conditions. The researchers want to understand if it can have an additional benefit for people with recurrent pancreatitis. They will carefully compare how often pancreatitis returns in those taking simvastatin versus those taking a dummy pill, to get a clear answer about its effectiveness.

Key takeaways

This study explores if simvastatin can prevent repeat pancreatitis attacks.
It's a fair test where participants receive either simvastatin or a dummy pill.
The study focuses on adults who have had pancreatitis come back.
Researchers will track how often pancreatitis returns and other health changes.
Simvastatin is already a widely used medicine for other conditions.
Your safety and comfort will be closely monitored throughout.

Who may be eligible?

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

The most important requirement is that you have experienced pancreatitis more than once, meaning you've had recurrent pancreatitis. The researchers are specifically looking for people who are struggling with this ongoing problem.

There will be other, more detailed health checks to make sure the study is safe for you and that the results will be clear. For example, they'll check if you have any other medical conditions or are taking medications that might interfere with simvastatin.

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 had pancreatitis more than once?
Are you able to attend regular appointments for the study?
Are you willing to potentially take either simvastatin or a dummy pill?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive simvastatin or a dummy pill (which contains lactose, a type of sugar, but no active medicine). You, your doctor, and the study team wouldn't know which one you're getting – this is to make sure the study is fair and unbiased.

You would take the assigned medication regularly for a period of time. Throughout the study, you'd have regular check-ups and appointments with the study team. They would monitor your health closely, ask about any symptoms you experience, and conduct tests to see if your pancreatitis returns. They will also look at how many times you might visit the emergency room or be admitted to hospital for stomach pain, and check for conditions like new-onset diabetes or signs of changes in your pancreas over time. The total duration of your involvement in the study would be clearly explained to you.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as simvastatin might help prevent future pancreatitis attacks. However, it's also possible you might receive the dummy pill and not experience any direct benefit from the study medication. Simvastatin, like all medicines, can have side effects. These can range from mild (like muscle pain or upset stomach) to more serious, although rare. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What is pancreatitis?

Pancreatitis is a condition where your pancreas, an organ behind your stomach, becomes inflamed. It can cause severe belly pain.

What is simvastatin?

Simvastatin is a common medicine usually prescribed to lower cholesterol. This study is looking to see if it can also help with pancreatitis.

Why is this study 'triple blind'?

Triple blind means that you, your doctor, and the study researchers won't know if you're getting the actual medicine or a dummy pill. This helps make the study results as fair and accurate as possible.

What is a 'dummy pill'?

A dummy pill, also called a placebo, looks just like the real medicine but contains no active ingredients. It's used to compare against the active medicine.

Will I have to pay to join this study?

No, you will not have to pay to participate in this research study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.