drugset / Trial / NCT00142233

EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

NCT00142233

Phase 3 Completed 295 enrolled University Medicine Greifswald
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2005-06-06
Primary completion
2019-09
Completion
2019-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 7.5 mmol
Subject Magnesium Sulfate Other / unclassified 15 mmol

Indications