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Study on Metamizole Sodium Monohydrate for Pain Relief in Patients with Chronic Pancreatitis Diagnosed Less Than 3 Years Ago

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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 effectiveness of a medication called metamizole sodium monohydrate, also known as Dolamizol 500 mg tablet, in treating pain associated with chronic pancreatitis. Chronic pancreatitis is a long-lasting inflammation of the pancreas that can cause severe abdominal pain. The study aims to determine if taking metamizole three times a day, in addition to the current pain management treatments, can help reduce pain in patients who have been diagnosed with chronic pancreatitis for less than three years.

Participants in the study will be randomly assigned to receive either the metamizole medication or a placebo, which looks like the medication but does not contain the active ingredient. This is a double-blind study, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results. The study will take place over a period of four weeks, during which participants will record their daily pain levels using a simple numerical scale from 0 (no pain) to 10 (worst pain imaginable).

The main goal is to see if metamizole can effectively reduce the average daily pain intensity. Additionally, the study will look at other factors such as the number of pain-free days, the amount of additional pain medication needed, and overall patient satisfaction with the treatment. The study is expected to conclude by July 2025.

The research process

The trial runs in 7 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 based on specific criteria, including a diagnosis of chronic pancreatitis and experiencing typical abdominal pain for at least three days a week over two weeks.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the active medication, Dolamizol 500 mg tablet, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    The active medication, metamizole sodium monohydrate, is administered orally in a dosage of 1000 mg, three times daily. This is in addition to any current pain management therapy.

  4. Step 4

    Intervention period

    The intervention lasts for four weeks. During this time, participants record their daily pain intensity using an 11-point numerical scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.

  5. Step 5

    Data collection

    Throughout the trial, various data points are collected, including the mean daily pain intensity score, the number of pain-free days, and the total amount of additional pain medication required.

  6. Step 6

    Evaluation of outcomes

    The primary outcome is the reduction in mean daily pain intensity. Secondary outcomes include the Izbicki pain score, quality of life assessments, and patient satisfaction.

  7. Step 7

    Completion of the trial

    The trial is estimated to conclude by July 1, 2025. Participants' experiences and data collected will contribute to understanding the effectiveness of metamizole in managing pain associated with chronic pancreatitis.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of chronic pancreatitis. This is a long-lasting inflammation of the pancreas.
  • The patient must experience abdominal pain typical for chronic pancreatitis. This means a dull pain in the upper part of the belly, with a pain score of 3 or higher on a scale called the NRS (Numerical Rating Scale), occurring at least 3 days a week for two weeks.
  • The patient must be between the ages of 18 and 65 years old.
  • Both male and female patients can participate.
  • The patient should not belong to a vulnerable population, which means they should not be in a group that needs special protection or care.

Who cannot join the trial?

7 criteria

  • Patients who have been diagnosed with **chronic pancreatitis** for more than 3 years cannot participate. **Chronic pancreatitis** is a long-lasting inflammation of the pancreas, an organ that helps with digestion and blood sugar regulation.
  • Patients who are not experiencing pain related to their **chronic pancreatitis** are excluded. The study focuses on those who have pain due to this condition.
  • Patients who are allergic to **metamizole** cannot participate. **Metamizole** is a medication used to relieve pain and reduce fever.
  • Patients who are currently taking medications that might interact negatively with **metamizole** are excluded. This is to ensure safety and avoid any harmful effects.
  • Patients with severe liver or kidney problems cannot participate. These organs are important for processing medications, and severe issues could lead to complications.
  • Pregnant or breastfeeding women are excluded to avoid any potential risks to the baby.
  • Patients who are participating in another clinical trial are not allowed to join this study. This is to prevent any interference with the results of either study.
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Investigated drugs

Metamizole is being studied as a treatment for pain in patients with chronic pancreatitis. The trial aims to determine if taking metamizole three times a day can effectively reduce pain when added to the current pain management therapy for these patients.

What is already known about the treatment

Metamizole – Metamizole is administered orally in tablet form and is being studied for its effectiveness in reducing pain in patients with chronic pancreatitis. It is currently under investigation in a clinical trial to determine its efficacy when added to existing pain management therapies. The main therapeutic indication for metamizole in this trial is pain relief for chronic pancreatitis. At the molecular level, metamizole works by inhibiting the production of certain chemicals in the body that cause inflammation and pain. It is classified pharmacologically as a non-opioid analgesic.

Investigated diseases

Chronic pancreatitis – Chronic pancreatitis is a long-lasting inflammation of the pancreas that alters its normal structure and functions. It is characterized by persistent abdominal pain, which can be severe and debilitating. Over time, the inflammation can lead to scarring and damage to the pancreas, affecting its ability to produce digestive enzymes and insulin. This can result in digestive problems and diabetes. The condition often progresses slowly, with symptoms worsening over time. It is commonly associated with repeated episodes of acute pancreatitis or long-term alcohol use.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504143-14-00Estimated enrolment76 patientsSponsorStichting Radboud universitair medisch centrum

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