NCT00142233

EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

Double Blind Randomised Controlled Trial to Investigate the Efficacy of ANTOX (Vers) 1.2 and MGCT (Magnesiocard) for the Treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 5 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ANTOX (vers.)1.2	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)
DRUG	Magnesium	15 mmol per day (for patients of 10 years and older) 7,5 mmol per day (for patients aged between 5 and 9 years)
OTHER	Placebo ANTOX (vers)1.2	Placebo ANTOX (vers)1.2
OTHER	Placebo Magnesiocard (2.5 mmol)	Placebo Magnesiocard (2.5 mmol)

Timeline

• Start date: 2005-06-06
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2005-09-02
• Last updated: 2020-03-27