EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
Pancreatitis
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard), Hereditary Pancreatitis, idiopathic chronic pancreatitis
Eligibility Criteria
Inclusion Criteria: Patients must have had symptoms of pancreatitis for at least one year. Patients must be willing to be followed up regularly for at least one year. Patients aged 5 to 75 years of age. Individuals must have characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months) Patients with documented Hereditary Pancreatitis (HP), clinically defined or proven by gene mutations in the PRSS1 Gene, or patients with Idiopathic Chronic Pancreatitis (ICP) and no mutations detected in the PRSS1 gene. This may include patients with a history of alcohol intake who have been abstinent for at least 24 month. Exclusion Criteria: Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved. Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements. Patients who have had recent treatment (<3 months), or are currently receiving treatment with antioxidants or magnesium tablets. Patients who have had recent (<3 months), or are currently receiving treatment with oral steroids for their pancreatic disease. Patients with renal failure (serum creatinine 200 µg/l). Patients with atrio-ventricular-block. Serum triglyceride levels >= 1000 mg/dl. Patients under the age of five years or over the age of 75 years. 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 who are participating in another drug trial. Patients who are pregnant. Women of childbearing age who are not using contraception. Lactating mothers. Any disorder that would prevent adequate absorption of the active treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
ANTOX (vers.)1.2
Magnesium
Placebo
Adults and children aged 10+ will take two ANTOX (vers)1.2 tablets three times per day. (Antioxidant treatment: daily: 300 μg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine) plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one ANTOX (vers)1.2 tablet three times daily (Antioxidant treatment: daily: 150 μg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine) plus one placebo Magnesiocard (2.5 mmol) tablet three times a day.
Adults and children aged 10+ will take two Magnesiocard (2.5 mmol) tablets three times per day (total dose: 15 mmol = 365 mg per day) plus two placebo ANTOX (vers)1.2 tablets three times a day. Children aged five to nine years of age will take one Magnesiocard (2.5 mmol) tablet three times a day (total dose: 7.5 mmol = 182 mg per day) plus one placebo ANTOX (vers)1.2 tablet three times a day.
Adults and children aged 10+ will take two placebo ANTOX (vers)1.2 tablets three times a day, plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one placebo ANTOX (vers)1.2 tablet three times a day, plus one placebo Magnesiocard (2.5 mmol) tablet three times per day.