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EUROPAC2   

Title

European Registry of Hereditary Pancreatitis and Familial Pancreatic Cancer (EUROPAC)2 trial to investigate the efficacy of antioxidants and magnesium for the treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis.


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Recruitment
III Treatment Open Age 5 - 65 (UK Co-sponsors) University of Liverpool and RLBUHT Eudract No: 2006-000087-83
Isrctn No: 44912429
256

Purpose

Both Hereditary and idiopathic Chronic Pancreatitis present early in childhood, with clearly defined episodes of pancreatic pain. Both conditions have a high risk for the development of complications of pancreatitis and ultimately pancreatic cancer. A targeted, low toxicity treatment administrated early in disease progression is desirable, both to reduce the number of exacerbations and potentially modify disease progressions.
The role of antioxidants in symptom modifications in Hereditary Pancreatitis has not been evaluated by a randomised controlled trial, although a number of studies suggest that they may be beneficial. The usefulness of magnesium therapy has been demonstrated in an animal model of acute pancreatitis. Regardless of whether magnesuim was administrated as a prophylactic or therapeutic infusion it reduced the premature intrapancreatic activation of digestive proteases in the pancreas and had a beneficial effect on the course of experimental pancreatitis.


Trial Start Date

16/05/2007


Trial Coordinator

Lucy Read


Trial Coordinator Email Address

lucy.read@liverpool.ac.uk


Trial Coordinator Contact No

0151 795 7327


Website Treatment  

EUROPAC2 is an international, multicentre, randomised, phase III, double blind, placebo controlled, parallel group, outpatient study in patients aged 5-65 with Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis. The trial will recruit 240 patients across three arms; Antox (vers)1.2 plus placebo MGCT, MGCT plus placebo Antox vers(1.2) or Placebo Antox (vers)1.2 plus placebo MGCT. UK sites are managed by the Liverpool Cancer Trials Unit and non-UK sites are managed by the co-ordinating centre in Greifswald, Germany

Trial Endpoints  

The objective of this study is to determine the efficacy of ANTOX (vers)1.2 and MGCT (Magnesiocard�) compared to placebo in the treatment of pain in patients with hereditary pancreatitis and idiopathic chronic pancreatitis


Primary Outcome  

  • Pancreatic pain, defined as the number of days of typical 'pancreatic' pain during one year, calculated by the number of days recorded with any pancreatic pain


Secondary Outcomes  

  • Intensity of pain recorded using a score (0-10) where 0 is no pain and 10 is the worst pain imaginable.
  • Analgesic consumption assessed using 'morphine equivalents'
  • The number of days spent in hospital due to painful exacerbations of pancreatitis or due to complications arising due to pancreatitis will be obtained from the patient. The clinician responsible for the care of the patient will independently verify this.
  • Quality of Life (QoL) including activities of daily living.

Eligibility  

INCLUSION

  • Patients with pancreatitis diagnosed for at least one year
  • Patients with documented HP, clinically defined or proven by genetic mutations in the PRSS1 gene, or patients with ICP and no mutations detected in the PRSS1 gene
  • Patients aged 5-65
  • Patients with characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months)
  • Patients who have provided written informed consent
  • Patients who are willing to be followed up regularly for at least one year
  • Patients who are able and willing to complete Quality of Life and Pain Assessment questionnaires
  • Patients who are able and willing to provide urine and faecal samples within two weeks of each study visit

EXCLUSION

  • Patients that do not consent to be involved in the trial or patients under the age of 16 whose parents/guardians do not consent for them to be involved in the trial
  • Patients or parents/guardians of underage patients with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements
  • Patients who are currently receiving treatment with antioxidants or magnesium tablets or have had such treatment in the within the last 3 months
  • Patients who are currently receiving treatment with oral hypoglycaemics or steroids or who have had such treatment within the last 3 months
  • Patients with renal failure (serum creatinine = 200�mol/l)
  • Patients with atrio-ventricular block
  • Serum triglyceride levels = 1000mg/dl
  • Patients who are dependent on daily opiate analgesia (morphine or equivalent for more than 12 months)
  • Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function
  • Patients or parents/guardians of underage patients with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements
  • Patients who are participating in another drug trial
  • Patients who are pregnant
  • All men and women of reproductive potential unless using at least two types of contraception, one of which must be a condom
  • Lactating mothers
  • Patients with any disorder which would prevent adequate absorption of the active treatment
  • Patients suffering from schizophrenia
  • Patients who smoke > 20 cigarettes per day

UK: ENGLAND

  • Bristol, Bristol Royal Hospital for Children (Dharamveer Basude)
  • Burton-upon-Trent, Queen's Hospital (Burton-upon-Trent) (Tim Reynolds)
  • Leeds, Leeds General Infirmary (Naved Alizai)
  • Liverpool, Alder Hey Children's Hospital (Liverpool) (Marcus Auth)
  • Liverpool, Royal Liverpool University Hospital (John Neoptolemos)
  • London, Great Ormond Street Hospital for Sick Children (London) (Keith Lindley)
  • London, King's College Hospital (London) (Babu Vadamalayan)
  • London, Royal London Hospital (Sandhia Naik)
  • Manchester, Royal Manchester Children's Hospital (Adrian Thomas)
  • Newcastle upon Tyne, Royal Victoria Infirmary (Newcastle) (Julian Thomas)
  • Nottingham, Queen's Medical Centre (Nottingham) (Guruprasad Aithal)
  • Southampton, Southampton General Hospital (Zaed Hamady)
  • Truro, Royal Cornwall Hospital (Truro) (Andrew Collinson)
  • Yeovil, Yeovil District Hospital (Zubair Khan)

UK: ENGLAND

  • , Freeman Hospital (Richard Charnley)
  • , North Staffs University Hospital (Derby) (Mark Deakin)
  • Birmingham, Birmingham Children's Hospital (Sue Protheroe)
  • Crewe, Leighton Hospital (Crewe) (John Slavin)
  • Hastings, Conquest Hospital (Johan Rademaker)
  • Leicester, Leicester General Hospital (Ashley Dennison)
  • London, Royal Free Hospital (London) (Stephen Pereira)
  • London, University College Hospital (London) (Stephen Pereira)
  • Manchester, Manchester Royal Infirmary (Alistair Makin)
  • Manchester, North Manchester General Hospital (Derek O'Reilly)
  • Milton Keynes, Milton Keynes General Hospital (Sandro Lanzon-Miller)
  • Plymouth, Derriford Hospital (Plymouth) (Andrew Kingsnorth)
  • Sheffield, Northern General Hospital (Sheffield) (James Gardner-Thorpe)

UK: SCOTLAND

  • Glasgow, Glasgow Royal Infirmary (Ross Carter)

Interactive Map  

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Frequently Asked Questions  

If you have any questions please email the coordinator on s.c.jones@liv.ac.uk

Links  

../docs/Leaflets/europac2.pdf#EUROPAC2 Leaflet, ../crfs/login.asp#Download CRFs (login required)