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Study on Simvastatin for Preventing Recurrent Pancreatitis in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of Simvastatin in preventing recurrent episodes of pancreatitis. Pancreatitis is a condition where the pancreas, an organ that helps with digestion, becomes inflamed. The study aims to see if taking Simvastatin can reduce the number of new pancreatitis episodes in people who have had it before. Simvastatin is a medication commonly used to lower cholesterol levels, and it is being tested here for its potential benefits in pancreatitis.

Participants in the study will be randomly assigned to receive either Simvastatin or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be "triple-blind," meaning that the participants, the healthcare providers, and the researchers do not know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The treatment period will last for up to 12 months, during which participants will take the medication orally in the form of a film-coated tablet.

The main goal of the study is to compare the number of new pancreatitis episodes between those taking Simvastatin and those taking the placebo. Additionally, the study will look at other factors such as the development of new health issues like diabetes or pancreatic insufficiency, the severity of pancreatitis episodes, and the number of hospital visits due to abdominal pain. The results of this study could provide valuable information on whether Simvastatin can be an effective treatment for preventing recurrent pancreatitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be adults aged 18 or older, with at least two episodes of acute pancreatitis or chronic pancreatitis. Written consent is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either simvastatin or a placebo. This process is triple-blind, meaning that neither the participants, the healthcare providers, nor the researchers know who receives the actual medication.

  3. Step 3

    Medication administration

    Participants take the assigned medication orally. The medication includes simvastatin and lactose monohydrate. The dosage and frequency are determined by the study protocol and are administered consistently throughout the trial.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for new episodes of pancreatitis and other health changes. This includes tracking the recurrence of pancreatitis, the development of new conditions such as diabetes or pancreatic insufficiency, and the severity of any recurrent pancreatitis episodes.

  5. Step 5

    Data collection

    Data is collected on the number of hospital admissions, emergency room visits, and any imaging signs of chronic pancreatitis. This information helps assess the effectiveness of simvastatin in preventing recurrent pancreatitis.

  6. Step 6

    Completion of the trial

    The trial is estimated to end by April 1, 2025. At this point, the collected data will be analyzed to determine the impact of simvastatin on preventing recurrent pancreatitis.

Who can join the trial?

3 criteria

  • Must be an adult, which means 18 years or older.
  • Must have had at least 2 episodes of acute pancreatitis (AP) or episodes of chronic pancreatitis. Pancreatitis is when the pancreas, an organ in your body, becomes inflamed or swollen.
  • Must provide written consent to participate in the study, which means you agree in writing to be part of the research.

Who cannot join the trial?

8 criteria

  • Patients who have a history of **allergic reactions** to simvastatin or similar medications. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
  • Patients who are currently taking medications that can interact negatively with simvastatin. Some medications can cause problems when taken together, so it's important to avoid these combinations.
  • Patients with **liver disease**. The liver is an organ that helps process medications, and if it's not working well, it can cause problems with how the medication works in your body.
  • Patients with **kidney disease**. The kidneys help remove waste from the body, and if they are not working properly, it can affect how the medication is processed.
  • Women who are pregnant or breastfeeding. Some medications can affect the baby, so it's important to avoid them during pregnancy and breastfeeding.
  • Patients who have had a recent **heart attack** or **stroke**. A heart attack is when blood flow to the heart is blocked, and a stroke is when blood flow to the brain is blocked. Both are serious conditions that require special care.
  • Patients with **uncontrolled diabetes**. Diabetes is a condition where your blood sugar levels are too high, and if it's not controlled, it can cause complications with the medication.
  • Patients who are participating in another clinical trial. Being in more than one trial at a time can affect the results and your health.
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Investigated drugs

Simvastatin is a medication used in this trial to see if it can help prevent new episodes of recurrent pancreatitis. It is commonly used to lower cholesterol and reduce the risk of heart disease, but in this study, researchers are investigating whether it can also reduce the frequency of pancreatitis attacks.

What is already known about the treatment

Simvastatin – Simvastatin is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential to prevent recurrent pancreatitis. The main therapeutic indication for simvastatin is to lower cholesterol and triglyceride levels in the blood, which can help prevent heart disease. At the molecular level, simvastatin works by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. It is classified as a statin, a type of medication used to manage high cholesterol levels.

Investigated diseases

Recurrent Pancreatitis – Recurrent pancreatitis is a condition characterized by repeated episodes of inflammation in the pancreas. This inflammation can cause abdominal pain, nausea, and vomiting. Over time, the repeated inflammation can lead to damage of the pancreatic tissue. This damage may result in the development of scar tissue, which can affect the pancreas's ability to function properly. As the condition progresses, individuals may experience complications such as digestive issues or diabetes. The frequency and severity of episodes can vary among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513188-17-03Protocol codeSIMBA-16Estimated enrolment144 patientsSponsorHospital General Universitario Dr. Balmis

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