EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
Recruitment status was Recruiting
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.
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)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Reduction in the number of days of pancreatic pain during 12 continuous months of treatment.
- 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.
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||December 2008|
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
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.
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
|Contact: Markus M Lerch, Professor of Medicine||03834-86 ext email@example.com|
|Contact: Julia V Mayerle, MD||03834-86 ext firstname.lastname@example.org|
|Department of Visceral and Transplant Surgery, Ruprecht-Karls-Universität Heidelberg||Recruiting|
|Heidelberg, Baden-Würtemberg, Germany|
|Contact: Jeannine Bachmann, MD +49/6221/56 ext 36459 email@example.com|
|Contact: Helmut Friess, Professor of Surgery ++49/6221/56 ext 6902 firstname.lastname@example.org|
|Principal Investigator: Helmut Friess, Professor of Surgery|
|Sub-Investigator: Jeannine Bachmann, MD|
|Principal Investigator:||Markus M Lerch, Professor of Medicine||Department of Gastroenterology, Endocrinology and Nutrition, Ernst-Moritz-Arndt University Greifswald|
|Principal Investigator:||Julia V Mayerle, MD||Department of Gastroenterology, Endocrinology and Nutrition, Ernst-Moritz-Arndt University Greifswald|
|Principal Investigator:||John P Neoptolemos, Professor of Surgery||Department of Surgery, University of Liverpool|