EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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 288 patients will be randomised to one of three treatment groups in order to
      compare pancreatic pain over a twelve month period.
    

Detailed description: 
      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 288 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: 300 µg
      organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day.

      Group two: Two Magnesium-L-Aspartate-hydrochloride (Magnesiocard 2,5 mmol (MGCT)) tablets,
      three times daily, total dose 15 mmol (365 mg) per day.

      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
    

Intervention name(s): ANTOX (vers.)1.2; Magnesium; Placebo ANTOX (vers)1.2; Placebo Magnesiocard (2.5 mmol)
Intervention type(s): Dietary Supplement; Drug; Other; Other
Intervention description(s): 300 µg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day (for patients of 10 years and older)
150 µg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine per day (for patients aged between 5 and 9 years); 15 mmol per day (for patients of 10 years and older)
7,5 mmol per day (for patients aged between 5 and 9 years); Placebo ANTOX (vers)1.2; Placebo Magnesiocard (2.5 mmol)
Other intervention name(s): Magnesiocard (MGCT)
Intervention MeSH terms: N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard); Hereditary Pancreatitis; idiopathic chronic pancreatitis