• Disruption of activities of normal living.
• Analgesic use for pancreatic pain.
• Number of days of hospitalisation for conditions related to pancreatitis.
• Quality of life (QoL) measures.
• Markers of inflammatory response and activity of the pancreas.
• Changes in urinary levels of magnesium, selenium, and vitamin C over the duration of the study.
• Antioxidant response as measured by urinary thiobarbituric acid levels.
• Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
• Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, CFTR, other).
• Data acquisition including markers of inflammatory response during acute attack of chronic pancreatitis.

• Disruption of activities of normal living.
• Analgesic use for pancreatic pain.
• Number of days of hospitalisation for conditions related to pancreatitis.
• Quality of Life (QoL) measures.
• Markers of inflammatory response and activity of the pancreas.
• Changes in urinary levels of magnesium, selenium and vitamin C over the duration of the study.
• Antioxidant response as measured by urinary thiobarituric acid levels.
• Response in patients with Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis.
• Correlate response with gene mutations underlying Hereditary Pancreatitis (PRSS1, other) and Idiopathic Chronic Pancreatitis (SPINK1, CFTR, other).
• Data acquisition including makers of inflammatory response during acute attack of chronic pancreatitis.

This is a multi-centre randomised phase III, double blind, placebo controlled, parallel group, outpatient study in patients diagnosed with hereditary pancreatitis and idiopathic chronic pancreatitis.

The hypothesis to be tested is a 30% reduction in the number of days due to pancreatitis from 12.5 days per year to less than nine days per year under the treatment with magnesium or an antioxidant cocktail called ANTOX.

A total of 240 patients will be randomised to one of three treatment groups in order to compare pancreatic pain over a twelve month period.

Title: EUROPAC 2 trial to investigate the efficacy of ANTOX (vers) 1.2 and MGCT (Magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis

Study drug: ANTOX (vers) 1.2 MGCT (Magnesiocard)

Intended indication: Hereditary pancreatitis and idiopathic chronic pancreatitis

Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study

Patient population: Patients with hereditary pancreatitis or idiopathic chronic pancreatitis

Number of patients: Total of 240 patients in three equal groups

Proposed number of initial centres: two (Greifswald, Germany and Liverpool, UK).

Duration of dosing: 12 months

Treatment groups:

Group one: Two ANTOX (vers) 1.2 tablets, three times daily, Antioxidant treatment: Daily: 300 µg organic selenium, 54000 IU beta carotene = 18 mg, 750 mg vitamin C, 540 IU of vitamin E = 240 mg, 2700 mg methionine.

Group two: Two Magnesium-L-Aspartate-hydrochloride (MGCT) (Magnesiocard  2,5 mmol tablets three times a day, total dose 15 mmol ([365 mg/per day]) tablets.

Group three: The same number of tablets as in Groups one and two but placebo instead of active drug.

Efficacy parameters:

Primary: Pain (number of days of pancreatic pain)

Secondary: Severity of pain; analgesic use for pancreatic pain; number of days of hospitalisation for conditions related to chronic pancreatitis; quality of life; markers of inflammatory response, antioxidant response, changes in urinary levels of magnesium, selenium, vitamin C and activity of the pancreatitis and pancreatic function.

Safety parameters: Toxicity; Adverse events

• Drug: Magnesium (15 mmol/d)
• Drug: ANTOX (vers.) 1.2 (300 µg organic selenium, 54000 IU beta carotene, 750 mg vitamin C, 540 IU vitamin E, 2700 mg methionine)

Inclusion Criteria:

1. Patients must have had pancreatitis diagnosed for at least one year.
2. Patients must be willing to be followed up regularly for at least one year.
3. Patients aged 5 to 40 years of age.
4. Individuals must have characteristic pancreatic pain that is either intermittent or continuous.

Exclusion Criteria:

1. Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved.
2. Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements.
3. Patients who have had treatment < 3 months, or are currently receiving treatment with antioxidants or magnesium tablets.
4. Patients who have had recent (< 3 months), or are currently receiving treatment with oral hypoglycaemics or steroid treatment.
5. Patients with renal failure (serum creatinine  200 g/l).
6. Patients with atrio-ventricular-block.
7. Serum triglyceride levels  1000 mg/dl.
8. Patients under the age of 5 years or over the age of 40 years.
9. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months.
10. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological, or cerebral function.
11. Patients who are participating in another drug trial.
12. Patients who are pregnant.
13. Women of childbearing age who are not using contraception.
14. Lactating mothers.
15. Any disorder that would prevent adequate absorption of the active treatment.