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Study on Tocilizumab for Reducing Pain in Patients with Chronic Pancreatitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called tocilizumab on patients with chronic pancreatitis, a condition where the pancreas becomes inflamed over a long period, leading to pain and digestive problems. The trial aims to see if tocilizumab can help reduce the pain associated with this condition and improve the overall quality of life for those affected. Tocilizumab will be compared to a placebo to evaluate its effectiveness.

Participants in the study will receive either tocilizumab or a placebo through an infusion, which is a method of delivering medication directly into the bloodstream. The study will last for about 24 weeks, during which participants will have regular check-ups to monitor their health and any changes in their symptoms. The goal is to determine if tocilizumab can significantly reduce pain and improve physical functioning compared to the placebo.

Throughout the study, various assessments will be conducted to measure the impact of the treatment on pain levels and quality of life. These assessments will help researchers understand the potential benefits of tocilizumab for people with chronic pancreatitis. The study will also track the use of pain relief medications and any side effects experienced by participants to ensure a comprehensive evaluation of the treatment’s safety and effectiveness.

1 joining the study

Upon joining the study, the participant will have signed an informed consent form, confirming understanding and agreement to participate in the trial.

The participant must have a probable or definitive diagnosis of chronic pancreatitis, as defined by specific medical criteria.

2 initial assessment

An initial assessment will be conducted to confirm eligibility and establish baseline health status.

This may include medical history review, physical examination, and laboratory tests.

3 treatment phase

Participants will receive either tocilizumab or a placebo. Tocilizumab is administered as a solution for infusion.

The infusion will be given intravenously, meaning it is delivered directly into a vein.

The treatment will continue for a period of 24 weeks.

4 monitoring and assessments

Participants will be monitored regularly to assess the effects of the treatment.

Assessments will include questionnaires such as the COMPAT-SF, EORTC-QLQ-C30, and mBPI-SF to evaluate pain and quality of life.

These assessments will occur at weeks 12 and 24.

5 final evaluation

At the end of the 24-week treatment period, a final evaluation will be conducted.

This will include a review of the participant’s health status, pain levels, and any side effects experienced during the trial.

Who Can Join the Study?

  • The patient must provide a signed informed consent, which means they agree to participate after understanding the study details.
  • The patient should have a probable or definitive diagnosis of chronic pancreatitis (CP) based on specific criteria.
  • A definitive diagnosis of CP can be confirmed by one or more of the following:
    • Pancreatic calcification: Hard deposits in the pancreas.
    • Moderate or marked ductal lesions: Damage to the ducts in the pancreas, as per the Cambridge classification.
    • Exocrine pancreatic insufficiency: The pancreas doesn’t produce enough enzymes, leading to fatty stools, which improve with enzyme supplements.
    • Histological verification: Confirmation through tissue examination.
  • A probable diagnosis of CP can be confirmed by one or more of the following:
    • Mild ductal alterations, as per the Cambridge classification.
    • Recurrent or persistent pseudocysts: Fluid-filled sacs in the pancreas.
    • Abnormal pancreatic function tests, like the faecal elastase-1 test or secretin test.
    • Diabetes mellitus: A condition where blood sugar levels are high.
  • The patient must have abdominal pain believed to be from the pancreas, typically felt in the upper abdomen and radiating to the back.
  • There should be evidence of ongoing pancreatic inflammation, with a flare-up of pancreatic pain in the past six months, defined by one or more of the following:
    • Plasma amylase levels elevated to twice the usual level.
    • Elevated plasma levels of CRP (C-reactive protein) to twice the normal level, without signs of infection.
    • Signs of pancreatic inflammation on imaging tests.
  • The patient must be 18 years of age or older.
  • The patient must be able to read and understand the informed consent forms.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and participate in other trial procedures.

Who Cannot Join the Study?

  • Patients who are not diagnosed with chronic pancreatitis. This is a long-lasting inflammation of the pancreas, an organ that helps with digestion and blood sugar regulation.
  • Patients who are outside the specified age range for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

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Site Name City Country Status
Mckg Svroq Aalborg Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.03.2024

Trial locations

Investigated drugs:

Tocilizumab is a medication being studied for its potential to reduce pain and improve the quality of life in patients with chronic pancreatitis. It is believed that this medication may help decrease the symptom burden associated with this condition, particularly the pain that patients experience. Tocilizumab is typically used to treat certain types of arthritis and other inflammatory conditions, and in this trial, researchers are investigating its effectiveness in managing chronic pancreatitis symptoms.

Chronic Pancreatitis – Chronic pancreatitis is a long-lasting inflammation of the pancreas that alters its normal structure and functions. Over time, this condition can lead to permanent damage to the pancreas, affecting its ability to produce digestive enzymes and insulin. Patients often experience persistent abdominal pain, which can vary in intensity and may become more severe after eating. As the disease progresses, it can lead to malabsorption of nutrients, resulting in weight loss and nutritional deficiencies. Chronic pancreatitis can also cause diabetes due to the pancreas’s impaired ability to produce insulin. The condition is often associated with lifestyle factors, such as alcohol consumption, but can also be linked to genetic factors or other underlying health issues.

Trial ID:
2023-510084-35-00
Trial Phase:
Therapeutic exploratory (Phase II)

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