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 Pacreatitis.
Basic Trial Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
| III | Treatment | Open | Age 5 - 65 | University of Liverpool and RLBUHT | EUDRACT No: 2006-000087-83 ISRCTN No: 44912429 |
Trial Description
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.
Eligibility
- Patients with pancreatitis diagnosed for at least one year.
- Patients who are willing to be followed up regularly for at least one year.
- Patients aged 5 to 65 years of age.
- Individuals with characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months).
- Patients with documented HP, clinically defined or proven by gene mutations in the PRSS1 gene, or patients with ICP and no mutations detected in the PRSS1 gene.
- Patients/parents must consent to be involved in the trial,
- No 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.
Treatment/Intervention
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. The 9 UK sites will be managed by the LCTU and the continental European sites will be managed by 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.
- Inflammatory response and pancreatic activity measured at pre-defined time points assessed by the urinary amylase, the exocrine sufficiency marker, faecal elastase.
- Oxidant stress as measured by urinary thiobarituric acid, at fixed time points.
- Changes in the urinary levels of magnesium, selenium and vitamin C.
- Data acquisition including makers of inflammatory response during acute attack of chronic pancreatitis.
Trial Lead Organisations
Trial Sites
There are now 2 sites open in the trial:
- Royal Liverpool Hospital, Liverpool (Mr. Michael Raraty)
- Southampton General Hospital, Southampton (Mr. C. Johnson)
The following sites have expressed an interest:
- Birmingham Childrens Hospital, (Dr. S. Murphy)
- Bristol Royal Infirmary, (Miss Sally Norton)
- Derby City General Hospital, (Prof. Mike Larvin)
- Glasgow Royal Infirmary, Glasgow (Mr. R Carter)
- Newcastle General Hospital, Newcastle upon Tyne (Mr. Richard Charnley)
- University College Hospital, London (Dr. Stephen Pereira)
Registry Information
Official 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 Pacreatitis.
