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EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

NCT00142233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2020-03-27

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Markus M Lerch, Professor,MD · Klinik für Innere Medizin A, Universitätsmedizin Greifswald

  • Julia V Mayerle, Professor,MD · Medizinische Klinik II, Klinikum der Universität München

  • Christopher Halloran, Professor,MD,FRCS · Molecular and Clinical Cancer Medicine, University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-06
Primary Completion
2019-09-30
Completion
2019-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00142233 on ClinicalTrials.gov