A phase 3 trial comparing antioxidant and magnesium medication for people with hereditary and long term (chronic) pancreatitis (inflammation of the pancreas)
Full title: EUROPAC-2 Trial, A Double blind, randomised controlled trial to investigate the efficacy of ANTOX (vers) 1.2 and MGCT (Magnesiocard®) for the treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis
Why is this trial being carried out?
Pancreatitis is inflammation of the pancreas. Hereditary pancreatitis is a rare type of pancreatitis that runs in families. It causes frequent and painful inflammation of the pancreas. Chronic pancreatitis is long-term pancreatitis. It most often happens as a result of other causes such as gallstones, autoimmune disease, diabetes, pancreatic cysts or alcohol. People with chronic pancreatitis have similar symptoms, although there is no family history of pancreatitis.
With both conditions there is a risk of developing complications and pancreatic cancer at a later stage.
The EUROPAC-2 trial wants to find out how effective tablets containing antioxidants or magnesium are in helping to reduce the symptoms of pain related to pancreatitis. Antioxidants and magnesium are natural substances found in many foods that we eat, such as fruit and vegetables, and help the body to function properly.
On this trial researchers will compare an antioxidant tablet called ANTOX® with a magnesium tablet called Magnesiocard®. They will aim to find out:
- how well the tablets work in helping to reduce the intensity of pain from pancreatitis, and the number of days someone has pain for
- which tablet works best to reduce the pain
- the impact of each treatment on the quality of someone’s daily life
- whether each treatment reduces the number of days spent in hospital due to experiencing pain or complications.
If you take part in the trial you will take either ANTOX®, Magnesiocard® or a dummy (‘placebo’) treatment. The number of tablets that you will need to take will vary depending on your age. During the treatment neither you nor the doctor will know which treatment you are receiving or whether you will receive the placebo, as this could affect the results of the study. The treatment that you receive will be decided in a process known as randomisation.
Who is the trial suitable for?
The EUROPAC-2 trial is open to people who have been diagnosed with pancreatitis for at least one year. It may be suitable for people:
- who are aged between five and 75
- who have hereditary pancreatitis or chronic pancreatitis
- where no changes (mutations) have been found in a gene called the PRSS1 gene
- Who have had at least two episodes of pancreatic pain in the last 12 months.
It is not suitable for you if you:
- are currently having treatment with steroids, oral hypoglycaemics, antioxidants or magnesium tablets, or have had any of these treatments in the last three months
- have other medical conditions such as renal failure or a heart condition – the trial team will discuss this with you
- have had pancreatic surgery since your last attack of pancreatitis, or are planning to have pancreatic surgery within the trial duration
- are under the age of 16 and your parents or guardians do not agree for you to be involved in the trial.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you or your child.
Recruitment start date: December 2010
Recruitment end date: March 2018
Published April 2016
Review date March 2018
The EUROPAC-2 trial is being carried out at:
- Royal Liverpool University Hospital, Liverpool
- Southampton General Hospital, Southampton
- University College London (UCL), London
- Queens Medical Centre, Nottingham
- Bristol Royal Children’s Hospital, Bristol
- Royal Victoria Infirmary, Newcastle upon Tyne
- Alder Hey Children’s NHS Foundation Trust, Liverpool
- Royal London Hospital, London
- Leeds General Infirmary, Leeds
- Yeovil District Hospital, Somerset
- Kings College London, London
- Great Ormond Street Hospital for Children NHS Foundation Trust, London
- Royal Cornwall Hospital, Cornwall
- Royal Free Hospital, London
Professor John Neoptolemos
You can contact the clinical trial coordinator:
Sarah Quinby, Liverpool Clinical Trials Unit, Liverpool
Telephone: 0151 794 8292
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about the EUROPAC-2 trial please visit the ClinicalTrials.gov website.
You can also read about another EUROPAC study here looking at two types of families – those with familial pancreatic cancer and those with hereditary pancreatitis.
For references used to develop this information please email us.