Pancreatitis chronic Trials in Disease

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

This trial, taking place in the Netherlands, is investigating whether metamizole sodium monohydrate can effectively reduce pain in patients who have been diagnosed with the condition within the last three years. The study involves taking metamizole tablets three times daily as an addition to current pain management treatments.

Who can participate: Adults between 18 and 65 years old with a confirmed diagnosis who experience typical upper abdominal pain with a severity score of at least 3 out of 10, occurring at least three days a week for two consecutive weeks.

Who cannot participate: Patients diagnosed more than three years ago, those without pain related to their condition, individuals allergic to metamizole, those taking medications that might interact with metamizole, patients with severe liver or kidney problems, pregnant or breastfeeding women, and anyone already participating in another clinical trial.

What the trial involves: This is a double-blind study, meaning neither participants nor researchers will know who receives the actual medication or a placebo. Over four weeks, participants will record their daily pain levels on a scale from 0 to 10. The main goal is to determine whether metamizole can reduce average daily pain intensity compared to placebo. Researchers will also track pain-free days, use of additional pain medication, and overall patient satisfaction. The trial is expected to conclude by July 2025.

Investigational drug: Metamizole sodium monohydrate (also known as Dolamizol 500 mg tablet) is a non-opioid pain reliever that works by reducing the production of chemicals in the body that cause inflammation and pain.

Study on Tocilizumab for Reducing Pain in Patients with Chronic Pancreatitis

This trial, conducted in Denmark, is examining whether tocilizumab can help reduce pain and improve quality of life for patients living with the condition. The medication will be compared against a placebo to evaluate its effectiveness.

Who can participate: Adults aged 18 years or older with a probable or definitive diagnosis must have abdominal pain believed to originate from the pancreas, typically felt in the upper abdomen and radiating to the back. Evidence of ongoing pancreatic inflammation within the past six months is required, which can be demonstrated through elevated blood enzyme levels, inflammation markers, or imaging tests showing pancreatic inflammation. Participants must be able to understand and sign informed consent forms and be willing to attend scheduled visits and follow the treatment plan.

Who cannot participate: Patients without a diagnosis of the condition, those outside the specified age range, and members of vulnerable populations requiring special protection or care.

What the trial involves: Participants will receive either tocilizumab or a placebo through intravenous infusion, which delivers medication directly into the bloodstream. The study lasts approximately 24 weeks with regular check-ups to monitor health and symptom changes. Throughout the trial, various questionnaires will assess pain levels, physical functioning, and quality of life at weeks 12 and 24. Researchers will also track the use of pain relief medications and any side effects to comprehensively evaluate the treatment's safety and effectiveness.

Investigational drug: Tocilizumab is an immunosuppressive medication, specifically a monoclonal antibody, that works by blocking the interleukin-6 receptor, which plays a role in the body's immune response. It is already approved for treating certain types of arthritis and other inflammatory conditions, and this trial is investigating its potential to manage pain and improve quality of life in patients with pancreatic inflammation.

Summary

These two ongoing clinical trials represent different approaches to managing the persistent pain that affects patients with this pancreatic condition. The Netherlands-based trial focuses on early-stage patients diagnosed within the last three years, testing an oral pain reliever taken three times daily over four weeks. The Denmark-based trial takes a different approach by investigating an immunosuppressive medication delivered through infusion over a longer 24-week period, targeting the inflammatory processes underlying the condition.

Both trials use placebo comparisons to ensure rigorous evaluation of treatment effectiveness. The geographic distribution shows research activity in Northern European countries, with each trial testing medications that have different mechanisms of action—one working directly on pain pathways and the other targeting inflammatory processes. These complementary approaches may eventually provide doctors and patients with more options for managing this challenging condition.